Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Herbal and Botanical

All Drugs and Chemicals

Cola

standard surgical resection using clamps and surgical ligatures

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Standard Surgical resection

resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

LIGASURE

The objective of this prospective randomized surgical trial is to evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures.

This research study is a prospective, randomized trial. Women who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants. Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation. Patients who are eligible for participation and who are willing to participate will be randomized during the surgical procedure to standard surgical resection using clamps and surgical ligatures versus resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon. The resection of these tissues will be performed as part of the usual surgical protocol for women with ovarian cancer and will not be done so unless the tissues are the sites of metastatic disease or if their removal would be performed for staging purposes.

Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand

A Prospective Randomized Surgical Trial Comparing the Efficacy of LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Standard Surgical Resection in Women With Stage IIIC or Stage IVA Epithelial Ovarian Cancer

To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures

University of Utah

standard surgical resection using clamps and surgical ligatures

Standard Surgical resection: standard surgical resection using clamps and surgical ligatures

Standard Surgical Resection

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Total

< 50 years

50-70 years

>70 years

Age, Customized

Sex: Female, Male

Mark Wade

Surgical Time

Overall Study

Thyroid Neoplasms

Thyroid Diseases

Thyroid Nodule

Head and Neck Neoplasms

Endoscopic procedure will be done by Harmonic ACE7+

Endoscopic procedure will be done by Ligasure

Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm

Ligasure

Harmonic

Jin Wook Yi, Professor

Jin Wook Yi, Dr.

Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.

* This is a prospective randomized controlled study. The principal investigator or another clinical investigator in charge will individually inform the patients about the study, on the day before surgery.
* When informed consent is obtained, an investigator in charge of randomization only, will randomize the patients.
* According to randomization, the experimental group will Ligasure and the control group will use Harmonic ACE 7+. Other than the randomized use of energy devices, the protocol for TOETVA is performed as usual.
* Operation time (from insertion of the laparoscopic camera to removal of the camera), number of times the camera was cleaned, intraoperative blood loss will recorded.
* Postoperative hospital stay, visual analog pain scale, blood cell count and inflammatory parameters, postoperative drain amount will recorded.
* Complications of thyroid surgery (vocal cord dysfunction, hypoparathyroidism) are compared for safety assessment.

Energy Device Study in Transoral Endoscopic Thyroidectomy

Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial

Surgery time during the thyroid lobectomy

Numbers of camera cleaning during the lobectomy

Estimated blood loss during the lobectomy

visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain)

Inha University Hospital

Assistant Professor

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels

LIGASURE energy device will be used for dissection of tissue and ligation of vessels

THUNDERBEAT

Jeffrey Milsom, MD

Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2

- Ligasure Population

Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2

- Ligasure Population: 60 subjects, with colon neoplasm or diverticulitis will be invited in the study after surgery is deemed necessary Study Procedures: This project will consist only of prospective data collection. No interventions will be done for research purpose. Data will be collected prospectively on: -Patients (before, during and after surgery) -The THUNDERBEAT and LigaSure instruments Data will be collected on data collection sheets and entered in a password protected database Primary Outcomes/Definitions- Overall time for dissection of the soft tissues necessary for specimen removal during colon resection, measured in minutes, from the start of colon mobilization to specimen removal from the abdominal cavity.

A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery

A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery

from the start of colon mobilization to specimen removal from the abdominal cavity

Total/Composite score (composite of 5 variables:hemostasis;sealing;cutting;dissection;and tissue manipulation) was measured by a score system from 1 to 5 (1 being worst and 5 best) for each of the 5 variables,weighted by Coefficient of Importance with weight distribution as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue Manipulation 0.1.). The final reported score is a weighted average.

Length of post surgical stay in the hospital measured in days

Measured by score from 1 to 5 where 1 means Heavy bleeding , hemostasis achieved with the instrument with more than 2 attempts, and 5 means No oozing at vessel or tissue site in entire surgical field .

Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable "Yes" or "No"

Delayed thermal injuries related to Energy devices that occur after surgery within 30 days of the surgical date, measured as categorical variables "Yes" or "No".

operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision

Olympus

Weill Medical College of Cornell University

Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.

THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels

THUNDERBEAT: Tissue dissection and vessels ligation

LIGASURE energy device will be used for dissection of tissue and ligation of vessels

LIGASURE: Tissue dissection and vessels ligation

Age, Continuous

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.

Body mass index(BMI)

American Society of Anesthesiologists Classification (ASA Class) and has 6 levels plus an indicator "E" for an emergency cases.ASA 1: A normal healthy patient, ASA 2: A patient with a mild systemic disease,ASA 3: A patient with a severe systemic disease that is not life-threatening, to ASA 6: A brain-dead patient whose organs are being removed with the intention of transplanting them into another patient.This trial enrolled patients with ASA 1 to 3.

ASA Class

Koianka Trencheva

Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher's exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.

Overall Time for Dissection of the Soft Tissues

compared between groups by the Wilcoxon rank-sum test

Versatility Score

Length of Post Surgical Stay in the Hospital

Dryness of the Surgical Field Average Score Mean/sd

Intraoperative Complication Related to the Energy Devices

Delayed Thermal Injuries Related to Energy Devices

Operative Procedure Time

Coagulants

Hemostatics

This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.

This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.

Vi-Sealer

Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure

Other AHD

Hyun Park

Min Jung Kim

This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.

Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.

Efficacy and Safety Evaluation of Vi-sealer

Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)

Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites

Medical costs according to hemostatic instrument use

Ergonomics and subjective hemostatic performances assessed by surgeons using the survey

Collect only for adverse events that have a relationship with medical devices for clinical trials

Professor

Symptoms and General Pathology

Musculoskeletal Diseases

Mouth and Tooth Diseases

Diseases and Abnormalities at or Before Birth

Pain, Postoperative

Pain

Micrognathism

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Analgesics

Antirheumatic Agents

Adjuvants, Anesthesia

Central Nervous System Depressants

Dexamethasone

Dexamethasone acetate

BB 1101

Diclofenac

Meperidine

The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.

Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.

The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.

Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.

The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device.

Neck dissection

Shih-An Liu, MD, PhD

The aim of this prospective randomized study was to investigate if the LigaSure vessel sealing system can reduce the operation duration and the postoperative drainage amount in patients undergoing neck dissection.

We compared the differences in perioperative and postoperative variables between LigaSure Small Jaw®-assisted and conventional neck dissection in head and neck cancer patients.

Patients who were scheduled to undergo neck dissection due to head and neck cancer were eligible for this study. After receiving a detailed explanation, all patients signed an informed consent form before randomization. The study group were treated using the LigaSure vessel sealing system (Small Jaw®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection. Relevant data included tumor-related variables, perioperative parameters, postoperative drainage status, postoperative subjective pain, and analgesic consumption amount were recorded and analyzed.

LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients

A Prospective Randomized Study of LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients

The duration from incision of cervial skin till the completion of lymph node dissection

Intraoperative blood loss was estimated by the sum of the volume in the suction bottle and the increased weight of wet gauzes containing blood after neck dissection.

The amount of drainage from closed system drainage tube

Visual analogue scale of subjective pain status after operation

The amount of analgesic consumption via oral ingestion after operation

The amount of injected form analgesic used (Meperidine 50 mg/ampule)

Taichung Veterans General Hospital

Attending physician

The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.

Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device.

Ligusure-assisted Neck Dissection

The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.

Conventional Neck Dissection

Age, Categorical

Taiwan

Oral cavity

Oropharynx

Thyroid gland

Others

Primary tumor site

Clinical N stage was in accordance with the guidelines of the American Joint Committee on Cancer (7th edition, 2009)

Briefly, the clinical N stage was described at below.

N0: No regional lymph node metastasis

N1: Metastasis in a single ipsilateral lymph node, 3 cm or less in greatest dimension

N2: Metastasis of regional lymph node(s), none more than 6 cm in greatest dimension

Basically, a better survival is expected in N0 stage yet a worse survival is anticipated in N2 stage.

Clinical N stage

Level I, II, III

Level I, II, III, IV

Level II, III, IV

Level of cervical lymph node is based on the anatomical location

Briefly, the level of cervical lymph node is described as below

Level I: Submental and submandibular nodes

Level II: Upper jugular nodes - Between posterior belly of digastric muscles superiorly and hyoid bone inferiorly

Level III: Middle jugular nodes - between the hyoid bone and cricoid cartilage

Level IV: Lower jugular nodes - between the cricoid cartilage and the clavicle

Level V: Posterior cervical or spinal accessory nodes, posterior to the sternocleidomastoid muscle

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand	NCT01549925	Epithelial Ovar...	Standard Surgic... LIGASURE	18 Years -	University of Utah
Energy Device Study in Transoral Endoscopic Thyroidectomy	NCT04320901	Thyroid Nodule Thyroid Cancer	Ligasure Harmonic	20 Years - 70 Years	Inha University Hospital
Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand	NCT01549925	Epithelial Ovar...	Standard Surgic... LIGASURE	18 Years -	University of Utah
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery	NCT02628093	Colon Cancer	THUNDERBEAT LIGASURE	18 Years -	Weill Medical College of Cornell University
Energy Device Study in Transoral Endoscopic Thyroidectomy	NCT04320901	Thyroid Nodule Thyroid Cancer	Ligasure Harmonic	20 Years - 70 Years	Inha University Hospital
Efficacy and Safety Evaluation of Vi-sealer	NCT05629611	Benign Gynecolo...	Vi-Sealer Ligasure Other AHD	20 Years - 65 Years	CHA University
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery	NCT02628093	Colon Cancer	THUNDERBEAT LIGASURE	18 Years -	Weill Medical College of Cornell University
Energy Device Study in Transoral Endoscopic Thyroidectomy	NCT04320901	Thyroid Nodule Thyroid Cancer	Ligasure Harmonic	20 Years - 70 Years	Inha University Hospital
LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients	NCT02597582	Head and Neck N...	Neck dissection	20 Years - 80 Years	Taichung Veterans General Hospital
Efficacy and Safety Evaluation of Vi-sealer	NCT05629611	Benign Gynecolo...	Vi-Sealer Ligasure Other AHD	20 Years - 65 Years	CHA University
Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy	NCT03125798	Lung Cancer Complication of...	LigaSure™ Monopolar elect...	18 Years - 85 Years	Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Spots Global Cancer Trial Database for ligasure

Every month we try and update this database with for ligasure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ligasure

Every month we try and update this database with for ligasure cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ligasure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.