Clinical trials: Laparoscopic Gynecologic Surgery
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.
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
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
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 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
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
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
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
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
Tissue Adhesions
A Randomized Multi-centre Study to Assess the Safety and Manageability of a Laparoscopic Adhesion Barrier in Women Undergoing Gynecologic Laparoscopic Surgery Followed by Second Look Laparoscopy
The purpose of this study is to obtain data on the safety and manageability of applying LABS™ to the uterus and other areas of surgical trauma in the pelvis and abdomen following laparoscopic gynaecologic surgery.
- Trial name
- LABS-1 (NCT02260115)
- Testing
- LABS™, Surgical Control
- Where
- 4 sites in Germany, Greece
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Actamax Surgical Materials LLC