Clinical trials: Gynecologic Surgical Procedures
Surgery
The TransEnterix European Patient Registry
An open label observational registry trial in which participating centers enroll subjects who had or will have a laparoscopically assisted surgery using the Senhance Surgical System.
- Trial name
- TRUST (NCT03385109)
- Testing
- Surgery
- Where
- Germany
- Volunteers
- 4,080 people
- Sponsor
- Asensus Surgical
Pain, Postoperative
Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain
To validate the morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.
- Trial name
- NCT00143169
- Where
- 8 sites in China
- Volunteers
- 220 people
- Sponsor
- Pfizer
Vulvar Intraepithelial Neoplasia, Condylomata Acuminata
Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study
The study is a single arm, retrospective, single-center, post market registry. The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial…
- Trial name
- NCT06297187
- Testing
- CUSA (Cavitronic Ultrasonic Surgical Aspirator)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Integra LifeSciences Corporation
Gynecologic Surgery
Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy
The study is designed to evaluate the safety of performing in-bag morcellation of uterus tissues during laparoscopic hysterectomy (LSH or TLH).
- Trial name
- NCT03216772
- Testing
- Olympus PK Morcellator in PneumoLiner
- Sponsor
- Olympus Surgical Technologies Europe
Adhesion
PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery
Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs.
- Trial name
- NCT05811585
- Testing
- ADEPT
- Where
- 2 sites in United States, Germany
- Volunteers
- 153 people
- Sponsor
- Baxter Healthcare Corporation
Ovarian Cancer, Cervical Cancer
A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.
- Conditions
- Ovarian Cancer, Cervical Cancer, Gynecologic Cancer
- Trial name
- NCT05318625
- Testing
- Gynaecological laparoscopic surgery (Sirius System)
- Where
- Hong Kong
- Volunteers
- 30 people
- Sponsor
- Precision Robotics (Hong Kong) Limited
Myomas, Ovary Cysts
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery
- Conditions
- Myomas, Ovary Cysts, Endometriotic Cysts, Adhesions
- Trial name
- BAP (NCT02166554)
- Testing
- Saline, Cross-linked Hyaluronan Hydrogel
- Where
- 7 sites in China
- Volunteers
- 216 people
- Sponsor
- BioRegen Biomedical (Changzhou) Co., Ltd
Thymoma, Mediastinal Tumor
Clinical Investigation of the da Vinci Surgical System
This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
- Conditions
- Thymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer
- Trial name
- NCT05682742
- Testing
- Robotic-assisted Surgery
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Intuitive Surgical
Ovarian Cysts, Endometriosis
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
- Conditions
- Ovarian Cysts, Endometriosis, Adhesions
- Trial name
- NCT00865488
- Testing
- ADHEXIL
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 80 people
- Sponsor
- OMRIX Biopharmaceuticals
Laparoscopic Gynecological Surgery
Human Factors Actual-Use Clinical Protocol
The purpose of this study is to confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use by representative users, use, and use environments as required for regulatory agency…
- Trial name
- CONTAIN (NCT04799210)
- Testing
- Eximis CS (Contained Segmentation) System
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Eximis Surgical
GYN Disorders
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications Generate real-world evidence in the use of the da Vinci Surgical Systems for gynecological indications within the German…
- Trial name
- GENERATE (NCT05867927)
- Testing
- Robotic-assisted surgery (da Vinci), Non-da Vinci Surgery
- Where
- 15 sites in Germany
- Volunteers
- 1,250 people
- Sponsor
- Intuitive Surgical
Hernia, Inguinal, Hernia, Ventral
A Study to Understand the Utility of the Force Feedback Instruments in Robotic Procedures Using da Vinci 5 Robot
The goal of this observational study is to understand the utility of force feedback instruments in surgeries that are done using the da Vinci 5 robot.
- Conditions
- Hernia, Inguinal, Hernia, Ventral, Colorectal, Thoracic
- Trial name
- NCT06879912
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Intuitive Surgical
Ovarian Cancer, Cervical Cancer
Sirius in Gynaecological Laparoscopic Surgery
Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.
- Conditions
- Ovarian Cancer, Cervical Cancer, Gynecologic Cancer
- Trial name
- NCT05048407
- Testing
- Gynaecological laparoscopic surgery (Sirius System)
- Where
- Hong Kong
- Volunteers
- 30 people
- Sponsor
- Precision Robotics (Hong Kong) Limited
Laparoscopic Gynecological Surgical Procedures
Clinical Validation Study of the Eximis CS (Contained Segmentation) System
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.
- Trial name
- NCT06572163
- Testing
- Eximis CS (Contained Segmentation) System
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Eximis Surgical
Tissue Adhesion, Gynecologic Surgery
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions
The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.
- Trial name
- NCT04063085
- Testing
- PROTAHERE Absorbable Adhesion Barrier, Hyalobarrier Gel, No treatment
- Where
- Taiwan
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- SciVision Biotech Inc.
Ureter Injury
IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
- Trial name
- NCT05954767
- Testing
- IS-001
- Where
- 8 sites in United States
- Volunteers
- 189 people
- Sponsor
- Intuitive Surgical
Pain, Postoperative
Compare Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery
To validate the analgesic efficacy and safety of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery
- Trial name
- NCT00150280
- Testing
- celecoxib and ibuprofen SR
- Where
- 6 sites in China
- Volunteers
- 132 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Myoma
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove…
- Trial name
- NCT00562471
- Testing
- Adhibit Adhesion Prevention Gel, Standard of Care Comparator
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Angiotech Pharmaceuticals
Adhesion
PMCF Study for COSEAL® in Gynecologic Surgery
The study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary.
- Trial name
- NCT05996809
- Testing
- Coseal
- Where
- 2 sites in United States, Italy
- Volunteers
- 200 people
- Sponsor
- Baxter Healthcare Corporation
Postoperative Pain, Hysterectomy
Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
- Trial name
- NCT00399568
- Testing
- IV Acetaminophen
- Where
- 27 sites in United States
- Volunteers
- 331 people
- Sponsor
- Mallinckrodt