CClinicalTrials.gg
CompletedNCT07031050SPAROUpdated Apr 13, 2026

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

An observational study in Sacrocolpopexy, sponsored by Distalmotion SA. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Distalmotion SA · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sacrocolpopexy
03

In context

Lead sponsor

Distalmotion SA is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients undergoing a sacrocolpopexy or sacrocervicopexy

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No

Interventions

  • Devicesacrocolpopexy or sacrocervicopexy

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

06

What researchers measure

Primary outcomes

  1. Primary safety outcome

    Occurrence of Clavien-Dindo grades III-V adverse events

    Time frame: up to 42 days after surgery

  2. Primary efficacy outcome

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

    Time frame: Intraoperative

07

Study locations

6 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07031050
Lead sponsor
Distalmotion SA
Collaborators
Confinis
Responsible party
Sponsor
First posted
Jun 22, 2025
Start date
May 19, 2025
Primary completion
Jan 6, 2026
Completion
Jan 6, 2026
Last update
Apr 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion