Status:
COMPLETED
Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
Lead Sponsor:
Distalmotion SA
Collaborating Sponsors:
Confinis
Conditions:
Sacrocolpopexy
Eligibility:
All Genders
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Key Trial Info
Start Date :
May 19 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 6 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07031050
Start Date
May 19 2025
End Date
January 6 2026
Last Update
April 13 2026
Active Locations (6)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany
2
Universitätsklinikum Bonn
Bonn, Germany
3
Krankenhaus St. Elisabeth
Damme, Germany
4
Universitätsmedizin Essen
Essen, Germany