Clinical trials: Gynecological Surgery
Hysterectomy, Partial Nephrectomy
Robotic MIS With Dexter
The purpose of this study is to confirm the perioperative and early postoperative safety and clinical performance of the Dexter Robotic System (Dexter Surgical System, Model DM-L6).
- Conditions
- Hysterectomy, Partial Nephrectomy, Right Colectomy
- Trial name
- NCT05537727
- Testing
- robotic-assisted surgery
- Where
- 5 sites in France, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- Distalmotion SA
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
Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures
Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study
The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.
- Trial name
- NCT02326870
- Testing
- AutoLap
- Where
- 4 sites in Israel, Netherlands
- Volunteers
- 33 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
Surgery
Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.
- Trial name
- Annexa-S (NCT04233073)
- Testing
- andexanet alfa
- Where
- 56 sites in United States, Austria and 4 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy
Versius Gynecology Study
The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and/or salpingo-oophorectomy
- Trial name
- NCT07289295
- Testing
- Versius Surgical System
- Where
- Poland
- Volunteers
- 46 people
- Sponsor
- CMR Surgical Ltd
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
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.
- Trial name
- NOBLE-Laparo (NCT03873181)
- Testing
- HEMOBLAST™ Bellows
- Where
- 8 sites in Austria, France and 1 more
- Volunteers
- 102 people
- Sponsor
- Biom'Up France SAS
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
- Trial name
- NOBLE-Open (NCT03873168)
- Testing
- HEMOBLAST™ Bellows
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 64 people
- Sponsor
- Biom'Up France SAS
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
Surgery, Surgery in Early Childhood
The Asensus Paediatric Robotic Registry
An open-label, observational, paediatric registry trial in which participating centers enroll subjects who had or will have a laparoscopically-assisted surgery using the Senhance Surgical System.
- Trial name
- miniTRUST (NCT07081828)
- Testing
- Surgery
- Where
- Germany
- Volunteers
- 37 people
- Sponsor
- Asensus Surgical
Wounds and Injuries, Hemostasis
The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.
The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.
- Trial name
- NCT06715696
- Testing
- "HANBIO" Gauze (Sterilized, 1% Collagen)
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- HAN Biomedical Inc
Gynecological Outpatient Surgery
Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries
This study is a multi-center, randomized, double-blind, Propofol parallel-controlled phase III clinical study, with the primary objective of evaluating the efficacy of Ciprofol vs.
- Trial name
- NCT04958746
- Testing
- Ciprofol, Propofol
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
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
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