Clinical trials: Gynecologic Surgeries
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
Gynecologic Disease, Gynecologic Cancer
Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology
GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological…
- Conditions
- Gynecologic Disease, Gynecologic Cancer, Endometriosis, Ovarian Cancer
- Trial name
- GynRNA (NCT06392997)
- Testing
- Saliva sample
- Where
- 13 sites in France
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- ZIWIG
Pelvic Organ Prolapse (POP), Synthetic Mesh
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery
- Trial name
- ProGYNious (NCT07497321)
- Testing
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Laparoscopic Surgery
Comparison FloShield Air System Versus Clearify Visualization System (D-HELP)
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.
- Trial name
- NCT02419911
- Testing
- Laparoscopic surgery, FloShield Defogging and Cleaning System, Clearify Defogging and Cleaning System
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- Minimally Invasive Devices, Inc.
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 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
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
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
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
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
Gynecologic Disease
To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
- Trial name
- antiadhesion (NCT02957500)
- Testing
- Mediclore® (adhesion barrier)
- Where
- South Korea
- Volunteers
- 198 people
- Sponsor
- CGBio 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
Uterine Fibroids, Fertility Disorders
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery
The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate…
- Trial name
- NCT01388907
- Testing
- Ringer lactate solution, Prevadh film
- Where
- 11 sites in France
- Volunteers
- 61 people
- Sponsor
- Medtronic - MITG
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.
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
Ureter Injury
A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
- Trial name
- NCT03937505
- Testing
- IS-001, No treatment
- Where
- 3 sites in United States
- Volunteers
- 94 people, healthy volunteers welcome
- 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.
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
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
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