RecruitingNCT07031050
Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
Sponsor
Distalmotion SA
Enrollment
50 participants
Start Date
May 19, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted sacrocolpopexy or sacrocervicopexy.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Aged > 18 years
- Women with symptomatic stage I or greater pelvic organ prolapse (POP-Q)
- Patient agrees to perform the 6-week follow-up assessment as per Standard of Care
Exclusion Criteria5
- Any planned non-urogynaecological concomitant procedures
- History of previous POP surgery, with the exception of transvaginal approaches without mesh implantation
- Previous surgery and/or radiation for urologic, gastrointestinal or gynecologic cancer
- History of Crohn's disease
- Chronic colitis
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Interventions
DEVICEsacrocolpopexy or sacrocervicopexy
Robotic-assisted sacrocolpopexy or sacrocervicopexy with the Dexter robotic surgery system
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07031050