Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Leiomyoma

Hemorrhage

Prolapse

Pelvic Organ Prolapse

Myofibroma

Pain

Pelvic Pain

Hyperplasia

Endometrial Hyperplasia

Adenomyosis

Uterine Hemorrhage

Pathological Conditions, Anatomical

Neurologic Manifestations

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Stuart Hart, MD

This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will measure acoustic and pressure data within the bladder. The measurements will be used to detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation of sound data with surgical data reported by the surgeon. These data will be used to develop algorithms to detect changes of baseline bladder and ureteral function. The algorithms will be tested in future clinical trials.

Electronic Catheter Stethoscope

Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery

University of South Florida

HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis

Philips MR guided HIFU system

Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States. Women are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. This study is the first step in this quest. We will study the novel use of magnetic resonance imaging (MRI) in enhancing the safety of the FDA approved technique to treat fibroids called High Intensity Focused Ultrasound (HIFU). The term 'high intensity focused ultrasound' means using ultrasound to heat and to thermally destroy tissue, in this case, uterine fibroids. The MRI system will allow us to watch the ultrasound path during treatment and monitor the temperature increase in the fibroid tissue that comes during the procedure.

In this pilot study, women with symptomatic fibroids will undergo MRI guided HIFU and then have a hysterectomy. This will allow us to confirm studies done in animals which show that it is possible to destroy specific tissue without harming normal tissue surrounding the targeted area.

The purpose of this clinical study is to confirm the safety and treatment capabilities of the Philips MR guided HIFU system for ablation of uterine fibroids. This is a single arm pilot study of 10 women who will undergo hysterectomy after the HIFU procedure. This study design of hysterectomy after treatment has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. Safety will be assessed by evaluating treatment accuracy, complications, and adverse events. Treatment capabilities will be assessed by evaluating the fibroid volume ablated and other factors related to the procedure feasibility and acceptance including procedure duration, time to return to normal activity, and pain scores at the time of the procedure.

Study population

The Philips MR-HIFU System is intended for ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine-sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients will be recruited by referral to gynecology and interventional radiology at the NIH Clinical Center. Candidates for enrollment will already have symptomatic uterine leiomyomas and be willing to undergo hysterectomy for treatment. It is estimated that of apparently eligible subjects, at least 30 women will have to be screened in person in order to identify 10 who will be eligible for this study. Other studies of fibroid treatments are currently ongoing at the NIH. Women who have been interested in, but have not been selected for enrollment in those studies and who appear to be eligible to this study will be contacted for potential enrollment.

Study design:

This study is a multi-center, single arm trial evaluating the safety and treatment capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine fibroid patients who are otherwise healthy women. All patients enrolled in the study will undergo hysterectomy within a window of 30 days following HIFU treatment. Patients who have symptomatic uterine fibroids, meet clinical indications for hysterectomy, are eligible according to the inclusion and exclusion criteria and provide informed consent will be enrolled in this study. This study design of treatment followed by hysterectomy has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. It is anticipated that women will participate in the study for a 3 month period to include the screening, HIFU treatment, hysterectomy and post hysterectomy follow-up.

The methodology used for this HIFU device capitalizes on the thermal properties of volumetric ablation rather than point ablation used by other focused ultrasound systems. Thus it is anticipated that this device will have a shorter treatment time compared to other HIFU machines. This HIFU system, via real-time MR thermometry monitoring, has automated thermal feedback during the procedure which may enhance safety. This pilot study will not only assess the safety of this device but will enable us to delineate the treatment capabilities of this system for future use in patients who want uterine sparing non-surgical treatment for symptomatic fibroids.

Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States. Women are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. This study is the first step in this quest. We will study the novel use of magnetic resonance imaging (MRI) in enhancing the safety of the FDA approved technique to treat fibroids called High Intensity Focused Ultrasound (HIFU). The term high intensity focused ultrasound means using ultrasound to heat and to thermally destroy tissue, in this case, uterine fibroids. The MRI system will allow us to watch the ultrasound path during treatment and monitor the temperature increase in the fibroid tissue that comes during the procedure.

In this pilot study, women with symptomatic fibroids will undergo MRI guided HIFU and then have a hysterectomy. This will allow us to confirm studies done in animals which show that it is possible to destroy specific tissue without harming normal tissue surrounding the targeted area.

The purpose of this clinical study is to confirm the safety and treatment capabilities of the Philips MR guided HIFU system for ablation of uterine fibroids. This is a single arm pilot study of 10 women who will undergo hysterectomy after the HIFU procedure. This study design of hysterectomy after treatment has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. Safety will be assessed by evaluating treatment accuracy, complications, and adverse events. Treatment capabilities will be assessed by evaluating the fibroid volume ablated and other factors related to the procedure feasibility and acceptance including procedure duration, time to return to normal activity, and pain scores at the time of the procedure.

Study population

The Philips MR-HIFU System is intended for ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine-sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients will be recruited by referral to gynecology and interventional radiology at the NIH Clinical Center. Candidates for enrollment will already have symptomatic uterine leiomyomas and be willing to undergo hysterectomy for treatment. It is estimated that of apparently eligible subjects, at least 30 women will have to be screened in person in order to identify 10 who will be eligible for this study. Other studies of fibroid treatments are currently ongoing at the NIH. Women who have been interested in, but have not been selected for enrollment in those studies and who appear to be eligible to this study will be contacted for potential enrollment.

Study design:

This study is a multi-center, single arm trial evaluating the safety and treatment capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine fibroid patients who are otherwise healthy women. All patients enrolled in the study will undergo hysterectomy within a window of 30 days following HIFU treatment. Patients who have symptomatic uterine fibroids, meet clinical indications for hysterectomy, are eligible according to the inclusion and exclusion criteria and provide informed consent will be enrolled in this study. This study design of treatment followed by hysterectomy has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. It is anticipated that women will participate in the study for a 3 month period to include the screening, HIFU treatment, hysterectomy and post hysterectomy follow-up.

The methodology used for this HIFU device capitalizes on the thermal properties of volumetric ablation rather than point ablation used by other focused ultrasound systems. Thus it is anticipated that this device will have a shorter treatment time compared to other HIFU machines. This HIFU system, via real-time MR thermometry monitoring, has automated thermal feedback during the procedure which may enhance safety. This pilot study will not only assess the safety of this device but will enable us to delineate the treatment capabilities of this system for future use in patients who want uterine sparing non-surgical treatment for symptomatic fibroids.

Primary Outcome parameters:

1. Verifying with MR imaging that the location of the HIFU lesion matches the expected location (binary)
2. Verifying with MR imaging that no unintended lesions are formed as a result of the treatment (binary)
3. Examining the uterine capsule and surrounding areas for unintended damage during hysterectomy (binary)
4. Evaluating any complications or adverse events that result from the MR-guided HIFU treatment (categorical)
5. Comparing the actual MR-measured ablated volumes to MR thermal dose predicted volumes (categorical)
6. Comparing the ablated volumes from histology to MR thermal dose predicated volume (categorical)
7. Ensuring on histopathologic examination of the uterus that the zones treated by MR-guided HIFU treatment are indeed necrosed (binary)

Secondary Outcome Parameters:

1. Pain and discomfort scores immediately before, during and after HIFU treatment:
2. Length of Hospital Stay (LOS)
3. Return to Activity

Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

The number of treatment-related Adverse Events (AE) reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of treatment-related Adverse Events per subject. Relatedness of an AE to the treatment was judged case-by-case by the investigator.

Count the number of participants in which both of the following conditions are satisfied: the fibroid treated area as shown on MRI images during treatment is the same as displayed on fibroids from histology slices after hysterectomy, and no unintended lesions are visible in the uterus.

Length of time to return to normal activity measured in number of days from HIFU treatment. Assessed by patient interviews during follow-up.

Pain Scores obtained by patient self-assessment on a 0-10 scale, with 0 corresponding to no pain and 10 corresponding to maximum pain.

Patient's self-assessed discomfort level on a 4-point scale, with: 0 = no pain; 1 = mild; 2 = moderate; 3 = severe.

Philips Healthcare

Adverse events assessed by patient questionnaire.

Only unexpected adverse events were reported in the "Other" Adverse Event Field.

All adverse events were reported including those not related to treatment.

HIFU Treatment

Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.

HIFU Treated

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Sarah Baxter

Safety was assessed per protocol; all 11 participants were evaluated for adverse events after HIFU treatment.

Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids

All participants who underwent hysterectomy following MR-HIFU treatment were included in this endpoint measure. Patients who refused hysterectomy were not included.

HIFU Treatment Equals Location Per Hysterectomy

Length of Time to Return to Normal Activities

Treatment Day: Baseline

Treatment Day: Recovery

Treatment Day: Discharge

24 hours after treatment

48 hours after treatment

72 hours after treatment

1 week after treatment

2 weeks after treatment

Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.

Analysed subject numbers were:

from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;

Numerical Range Scale (NRS) of Pain Level

Discomfort Level

Overall Study

Menopause

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Progesterone

Antineoplastic Agents, Hormonal

Lucron Depot, Leuprolide acetate for depot suspension

12.5 mg, administered as a once daily oral dose for 90 days.

Progenta

25 mg, administered as a once daily oral dose for 90 days.

50 mg, administered as a once daily oral dose for 90 days.

Lucron Depot

Administered as a once daily oral dose for 90 days.

Placebo

Ronald Wiehle, PhD

A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.

Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.

A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

A Single Dose lead-in PK Followed by a Randomized, Double-blinded, Controlled, Multiple Dose Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Electronic Catheter Stethoscope	NCT01463462	Pelvic Organ Pr... Gynecologic Can... Uterine Leiomyo... Adenomyosis Endometrial Hyp... Other Abnormal ... Pelvic Mass Pelvic Pain		18 Years -	University of South Florida
Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids	NCT00837161	Uterine Fibroid... Uterine Leiomyo...	Philips MR guid...	18 Years - 59 Years	Philips Healthcare
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata	NCT01069094	Uterine Leiomyo...	Progenta Progenta Progenta Lucron Depot Placebo	18 Years - 50 Years	Repros Therapeutics Inc.
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata	NCT01069094	Uterine Leiomyo...	Progenta Progenta Progenta Lucron Depot Placebo	18 Years - 50 Years	Repros Therapeutics Inc.
Electronic Catheter Stethoscope	NCT01463462	Pelvic Organ Pr... Gynecologic Can... Uterine Leiomyo... Adenomyosis Endometrial Hyp... Other Abnormal ... Pelvic Mass Pelvic Pain		18 Years -	University of South Florida

Spots Global Cancer Trial Database for uterine leiomyomata