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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-19

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sacrocolpopexy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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sacrocolpopexy or sacrocervicopexy

Robotic-assisted sacrocolpopexy or sacrocervicopexy with the Dexter robotic surgery system

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No