Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Myoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.

The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.

Halt Procedure

Mary Hinckley, MD

Micah Harris, MD

Erika Banks, MD

Karen R Abbott, MD

Jay Berman, MD

Jose G Garza Leal, MD

David Levine, MD

Rodolfo Robles Pemueller, MD

Jennifer Israel, MD

Richard S Guido, MD

James Macer, MD

The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.

In this single-arm study, subjects who have symptomatic uterine fibroids will have laparoscopic surgery in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.

Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation

Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.

An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).

Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.

Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.

The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life.

Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates "change" in symptoms, a negative number indicates a reduction in symptoms and therefore improvement.

Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates "change" in health and quality of life, a positive number indicates and improvement.

The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.

The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.

Acessa Health, Inc.

The Safety Set consisted of all subjects treated in the study.

Safety Set

In this single-arm study, subjects who have symptomatic uterine fibroids had the Acessa Procedure using the Halt Medical Proprietary Acessa System. The Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical radiofrequency (RF) Handpiece. The Generator provides sinusoidally-varying voltage at 460 kilohertz (kHz) to drive a current through the tissue to be ablated. The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction. During these controlled ablations, the Generator produces an alternating current which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient's uterine fibroids and treat all of her fibroids, and just the fibroids.

Halt Medical Acessa Procedure

Age, Categorical

Age US Sites (n=86)

Age Latin America (n=51)

Age, Continuous

Sex: Female, Male

United States

Mexico

Guatemala

Region of Enrollment

Subjects who met the initial inclusion exclusion criteria were enrolled and treated. Two subjects were later found to have baseline bleeding volumes outside of the protocol inclusion limits. All 137 Subjects comprised the Safety Set. The Full Analysis Set excluded the two subjects that did not meet the baseline bleeding criteria.

Laura Kemp, Sr. VP Clinical Affairs

50% change in MBF

40% change in MBF

30% change in MBF

22% change in MBF

Of the 137 subjects enrolled and treated under this protocol, 124 (90.5%) were considered "evaluable" in terms of their 1) ability to provide a menstrual blood loss assessment, 2) lack of concomitant disease that affects the menstrual cycle, 3) baseline menstrual blood loss was within protocol inclusion limits.

Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment

Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure

Device-related events are those that the investigator considered to be definitely, probably, or possibly related to the device.

Device Related Adverse Events

Procedure-related events are those that the investigator considered to be definitely, probably, or possibly related to the procedure, including those related to abdominal entry and anesthesia.

Procedural

Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure

The Per Protocol Set was the primary analysis set for surgical reintervention.

Surgical Reintervention 12 Months Post Treatment

Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment

Uterine volume assessment 12 months post treatment via contrast enhanced MRI

Change in Uterine Volume

Fibroid volume assessment 12 months post treatment via contrast enhanced MRI

Change in Fibroid Volume

The Full Analysis Set (FAS) was used in the analysis of the change in total uterine and fibroid volumes between baseline and 12 months post treatment. Of the 137 Subjects enrolled, two were excluded from the FAS because they did not meet all of the inclusion/exclusion criteria.

Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)

All treated subjects who met all inclusion and exclusion criteria and who completed the Symptom Severity Questionnaire at Baseline and 12 months.

Full Analysis Set - Symptom Severity

All treated subjects who met all inclusion and exclusion Criteria and who completed the HRQL questionnaire at both baseline and 12 months.

Full Analysis Set - Health Related Quality of Life (HRQL)

Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool.

All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.

Full Analysis Set - Month 12 Health Status Change

Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome)

Somewhat Satisfied/Effective

Moderately Satisfied/Effective

Very Satisfied/Effective

Patients were asked, overall, how satisfied with their uterine fibroid treatment.

Overall, Satisfaction With Uterine Fibroid Treatment

Patients were asked to respond in their opinion, how effective was this treatment in eliminating their symptoms.

How Effective Was This Treatment in Eliminating Symptoms

Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)

Overall Study

Symptoms and General Pathology

Hemorrhage

Pharmaceutical Solutions

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Natriuretic Agents

Coagulants

Amino Acids

Epinephrine

Vasopressins

Arginine Vasopressin

Racepinephrine

Epinephryl borate

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

Hemostatics

Arginine

In the epinephrine group, we used a dilute epinephrine, 0.5 mg of epinephrine (\[1/2\] vial of 1mg/mL) in 50 mL of saline solution, taking care to use no more than 20 mL of solution per a subject.

In the vasopressin group, a dilute vasopressin, 5 units in 50 mL of saline solution, taking care to use no more than 20 mL of solution per a subject was injected.

Vasopressin

Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Although hysterectomy is the definitive treatment of myomas, myomectomy remains the gold standard treatment for women desiring future fertility and uterine conservation3. However, bleeding is often a problem in myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic infection, and adhesions with infertility.

A number of interventions have been introduced to reduce hemorrhage during myomectomy. Two categories of interventions can be identified: (a) Vascular interventions on uterine and/or ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol, sulprostone, and gonadotropin-releasing hormone (GnRH) agonist4-11. Of these, intraoperative local injection of vasopressin causing vasospasm is most commonly used. However, there is not a wide consensus on the use of this agent because of serious side effects reported in literature. In addition, in several countries, including France and Italy, vasopressin has not been commercialized because of its potential adverse effects on cardiovascular system.

Epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. However, there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy. Furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents during myomectomy has never been conducted. To test the hypothesis that the injections of epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the investigators performed this randomized controlled study.

Vasopressin Versus Epinephrine in Myomectomy

Use of Vasopressin Versus Epinephrine to Reduce Hemorrhage During Myomectomy: a Randomized Controlled Trial

The operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.

CHA University

Professor

Reproductive Control Agents

Hormones

Ulipristal acetate

Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis

Transvaginal ultrasound

Anamnesis aims to collect data about age, BMI, previous hormonal therapies (such as ulipristal acetate or gonadotropin-releasing hormone agonists) with submucous uterine myomas

Anamnesis

Operative hysteroscopy allows a direct evaluation of number, size (diameter and volume), location and appearance of submucous uterine myomas. This exam allows the resection of the myomas.

Operative hysteroscopy

Simone Ferrero, MD, PhD

Simone Ferrero

Fabio Barra, MD

The aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram.

This tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy.

Overall, 10% of all uterine myomas are submucosal. These myomas spread into the uterine cavity, lifting the endometrial mucosa, and are a common cause of abnormal uterine bleeding, dysmenorrhea, early miscarriage and they may be a cause of infertility.

Hysteroscopic myomectomy is the surgical procedure of choice for the treatment of submucosal myomas, because it is minimally invasive and has the advantage of preserving the integrity of the uterine wall.

The characteristics of the myomas (size, number and location) enables the surgeon to choose the surgical approach that will provide the best outcome for the patient, and may predict the chances of a complete hysteroscopic resection of myomas in one procedure.

Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

A Retrospective Study for Developing a Nomogram for Predicting Change of Complete Myoma Resection During Hysteroscopic Myomectomy

Ospedale Policlinico San Martino

Principal Investigator

Laparoscopic myomectomy and supracervical hysterectomy using GYNECARE MORCELLEX

Laparoscopic myomectomy and supracervical hysterectomy using ROTOCUT G1

Laparoscopic myomectomy with GYNECARE MORCELLEX: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (GYNECARE MORCELLEX).

Laparoscopic supracervical hysterectomy using GYNECARE MORCELLEX: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of GYNECARE MORCELLEX. Abdominal cavity irrigation.

Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX

Laparoscopic myomectomy with ROTOCUT G1: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (ROTOCUT G1).

Laparoscopic supracervical hysterectomy using ROTOCUT G1: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of ROTOCUT G1. Abdominal cavity irrigation.

Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1

Fulvio Zullo, MD, PhD

To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent advances in laparoscopy an important role was assumed by the methods of tissue extraction. In particular electronic power morcellators have become instruments of large use in surgical practice.

The tissue morcellator is an endoscopic instrument indicated for cutting, coring and extracting tissue in operative laparoscopy, and it has a pivotal role during specific gynaecologic procedures as well as myomectomy and hysterectomy. The main advantages offered by electronic morcellator consist in reduction of operative time and of risk in hernia formation, this last due to the absence of fascia's tearing or stretching.

Recently, a new generation of tissue morcellator has been commercialized. In particular, GYNECARE MORCELLEX (Ethicon-Johnson \& Johnson Gateway, US) and ROTOCUT G1 (Karl Storz, Culver City, CA, US) are two tissue morcellators currently available. These instruments seem to offer advantages over the previous models in terms of precision, speed and durability. The most useful of this features seems to be the higher speed, in particular it has been calculated that they morcellate tissues approximately four times faster than those of the previous generation. The high speed that characterizes this new morcellator potentially results in reduced operative time with consequent benefits in other surgical outcomes such as postoperative pain and recovery time.

Even if both morcellator seems to be high-quality instruments, no study was designed until now to compare these two tools in a prospective fashion.

Patients with symptomatic uterine leiomyomas will be assessed for eligibility and will be enrolled in the present protocol-study.

At entry, in each woman age, parity, body mass index (BMI), menopausal, socioeconomic and work status, symptoms related to the gynecologic disease, previous major surgical laparotomies, and associated medical condition will be assessed.

All eligible patients will be randomized in single blocks using a central computer generating randomization lists (University of Catanzaro). The subjects will be assigned to one of four subgroups of surgical treatment, i.e. group A1 myomectomies performed using GYNECARE MORCELLEX, group A2 supracervical hysterectomies performed using GYNECARE MORCELLEX, group B1 myomectomies performed using ROTOCUT G1 and group B2 supracervical hysterectomies performed using ROTOCUT G1.

Before surgery, for each patient gynaecological and rectal examination, Papanicolau smear test, ultrasonographic and hysteroscopic assessment with endometrial biopsy will be performed.

For each surgical intervention the following parameters will be recorded: duration of surgical procedures, intra-operative blood loss, amount of blood transfusion, intra-operative complications, number of laparotomic conversion, postoperative pain, post-operative complications, hospital stay, and time to return to full activity and/or work.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Randomized Controlled Trial (RCT)Comparing GYNAECARE MORCELLEX Versus ROTOCUT GI Tissue Morcellators

GYNAECARE MORCELLEX Tissue Morcellator vs. ROTOCUT GI Tissue Morcellator: a Randomized Controlled Study

Johnson & Johnson

University Magna Graecia

Fluoxymesterone

Hand-assisted laparoscopic surgery for myomectomy

In HALS, a trocar of 5-mm calipers was inserted through the umbilicus. Next, suprapubic transverse skin incision of 3-4cm in length was made and a wound retractor (Alexis; Applied Medical, Rancho Santa Margarita, CA) was inserted through the suprapubic opening.

HALS

In open surgery, the patient was placed in the supine position and the operation was carried out in a standard manner as described elsewhere \[Luciano AA. Myomectomy. Clin Obstet Gynecol 2009;52:362-71.\].

Open surgery

Taejong Song, MD

The aim of this study was to evaluate the feasibility and usefulness of Hand-assisted laparoscopic surgery (HALS) for myomectomy, and compare it with the open approach in myomectomy.

Uterine myomas are the most common benign tumor of the female genital tract and the leading indication for hysterectomy. Despite the fact that laparoscopic myomectomy is becoming increasingly popular, laparoscopic myomectomy remains underutilized because of inherit limitations. The limitations include technical challenges such as dissection of the myoma from its bed using the correct plane or multilayer closure of the myoma bed and the concern about the strength of the suturing and the subsequent risk of uterine rupture. As a result, laparoscopic myomectomy is currently performed only by expert surgeons.

Hand-assisted laparoscopic surgery (HALS) is a unique surgical approach that may overcome the limitations of pure laparoscopic surgery. HALS is not only less invasive than open surgery but also causes less technical challenges than laparoscopic surgery based on its manual nature and ability to use retractors. In gynecologic field, HALS has also been employed in ovarian cancers and large ovarian tumors.

In theory, HALS seems appropriate procedure, similar to the open approach, for patients with multiple or huge myomas. To date, no report has evaluated the feasibility and usefulness of HALS compared with open surgery (OS).

Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy

A Randomized Controlled Trial of Hand-assisted Laparoscopic Myomectomy Versus Abdominal Myomectomy: Surgical Outcomes and Patient Satisfactions

Tissue Adhesions

Cicatrix

Fibrosis

Adhesion Barrier System is site-specific sprayable adhesion barrier gel administered on the surgical field to reduce risk of adhesion formation.

Laparoscopic surgery only without use of adhesion barrier

ADBLOCK

Rudy-Leon De Wilde, MD PhD

Adhesions are the most frequent complication of abdominopelvic surgery. They are internal scar tissues which form as a result of surgery which may abnormally join together what were once separate tissues and organs.

This study will assess the safety and usability of anti-adhesion agent (gel) when used after laparoscopic surgery.

The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse events in ADBLOCK and surgery only group) assessed at 28 days

Title: Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological surgery

Design: Randomised controlled study to assess the safety, manageability and usability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary removal of ('virgin') myomas in women wishing to improve pregnancy outcomes.

Use of ADBLOCK will be assessed against laparoscopic surgery alone in 30 patients (randomised 2:1 ADBLOCK/surgery) with a pneumoperitoneum ≤90minutes.

Clinical Site Locations:

* Oldenburg, Germany
* Neuss, Germany
* Berlin, Germany

Patient Population: Women who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes.

Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery

The rate of adverse events will be compared in treatment arm and control arm

Terumo Europe N.V.

Antineoplastic Agents

Leuprolide

Antineoplastic Agents, Hormonal

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)

PGL4001

leuprorelin

Dr Elke Bestel

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

PGL4001 Versus GnRH-agonist in Uterine Myomas

A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas

Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.

Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.

A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.

Menorrhagia is defined as a PBAC \> 100 during one menstrual period which approximates to a blood loss of \> 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.

The week 13 PBAC score was calculated using the last 28 days of treatment.

Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples

Difference in percentage of subjects reporting moderate or severe hot flushes:

Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.

Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.

The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids	NCT00874029	Uterine Fibroid... Uterine Myomas	Halt Procedure	25 Years -	Acessa Health, Inc.
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids	NCT00874029	Uterine Fibroid... Uterine Myomas	Halt Procedure	25 Years -	Acessa Health, Inc.
Vasopressin Versus Epinephrine in Myomectomy	NCT01861015	Uterine Myomas	Epinephrine Vasopressin	18 Years - 75 Years	CHA University
Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy	NCT04400942	Uterine Fibroid... Uterine Myomas	Transvaginal ul... Anamnesis Operative hyste...	18 Years -	Ospedale Policlinico San Martino
Vasopressin Versus Epinephrine in Myomectomy	NCT01861015	Uterine Myomas	Epinephrine Vasopressin	18 Years - 75 Years	CHA University
Randomized Controlled Trial (RCT)Comparing GYNAECARE MORCELLEX Versus ROTOCUT GI Tissue Morcellators	NCT00743080	Uterine Myomas	Laparoscopic my... Laparoscopic my...	18 Years - 80 Years	University Magna Graecia
Hand-assisted Laparoscopic Surgery (HALS) for Myomectomy	NCT01858454	Uterine Myomas	HALS Open surgery	18 Years - 70 Years	CHA University
Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery	NCT01745432	UTERINE MYOMAS	ADBLOCK	18 Years - 45 Years	Terumo Europe N.V.
PGL4001 Versus GnRH-agonist in Uterine Myomas	NCT00740831	Uterine Myomas	PGL4001 leuprorelin	18 Years - 50 Years	PregLem SA
Randomized Controlled Trial (RCT)Comparing GYNAECARE MORCELLEX Versus ROTOCUT GI Tissue Morcellators	NCT00743080	Uterine Myomas	Laparoscopic my... Laparoscopic my...	18 Years - 80 Years	University Magna Graecia
Single-port Access Laparoscopic-assisted Vaginal Hysterectomy	NCT01048931	Uterine Myomas Adenomyosis	single-port LAV...	30 Years - 70 Years	Taipei Veterans General Hospital, Taiwan

Spots Global Cancer Trial Database for uterine myomas