NCT07031050

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

June 5, 2025

Last Update Submit

April 10, 2026

Conditions

Sacrocolpopexy

Outcome Measures

Primary Outcomes (2)

  • Primary safety outcome

    Occurrence of Clavien-Dindo grades III-V adverse events

    up to 42 days after surgery

  • Primary efficacy outcome

    Successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

    Intraoperative

Interventions

sacrocolpopexy or sacrocervicopexyDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing a sacrocolpopexy or sacrocervicopexy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Krankenhaus St. Elisabeth

Damme, Germany

Location

Universitätsmedizin Essen

Essen, Germany

Location

Inselspital Bern

Bern, Switzerland

Location

Spitäler FMI AG

Interlaken, Switzerland

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 22, 2025

Study Start

May 19, 2025

Primary Completion

January 6, 2026

Study Completion

January 6, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CH(2)DE(4)