Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance

Recruiting

• Conditions: Sacrocolpopexy

• Registration Number: NCT07031050
• Lead Sponsor: Distalmotion SA

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 sacrocervicopexy.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-19
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary safety outcome	up to 42 days after surgery	Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome	Intraoperative	Successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

Trial Locations

Locations (6)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Krankenhaus St. Elisabeth; 🇩🇪 Damme, Germany

Universitätsmedizin Essen; 🇩🇪 Essen, Germany

Inselspital Bern; 🇨🇭 Bern, Switzerland

Spitäler FMI AG; 🇨🇭 Interlaken, Switzerland