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OpenTrials
Completed

NCT Number: NCT07031050

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

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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Key information

Conditions

Sacrocolpopexy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacrocolpopexy or sacrocervicopexy

Device

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

Primary outcomes

  1. Primary safety outcome

    Time frame: up to 42 days after surgery

    Occurrence of Clavien-Dindo grades III-V adverse events

  2. Primary efficacy outcome

    Time frame: Intraoperative

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

Sponsors and collaborators

Lead sponsor

Distalmotion SA

Industry

Collaborators

  • Confinis

Registry information

Acronym: SPARO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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