SacrocolpopexySPARONCT07031050
Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
An observational study of Sacrocolpopexy, run by Distalmotion SA at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacrocolpopexy
- What is being tested?
- sacrocolpopexy or sacrocervicopexy
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 19 May 2025to 6 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing a sacrocolpopexy or sacrocervicopexy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
Charité - Universitätsmedizin Berlin
Berlin
Universitätsklinikum Bonn
Bonn
Krankenhaus St. Elisabeth
Damme
Universitätsmedizin Essen
Essen
About this study
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.
- Conditions
- Sacrocolpopexy
- Being tested
- sacrocolpopexy or sacrocervicopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacrocolpopexy or sacrocervicopexyDevice
Robotic-assisted sacrocolpopexy or sacrocervicopexy with the Dexter robotic surgery system
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety outcome
Occurrence of Clavien-Dindo grades III-V adverse events
Measured: 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
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start19 May 2025
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SacrocolpopexyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Distalmotion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Confinis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031050
- Sponsor's protocol ID
- 2024-03
- Acronym
- SPARO
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance
- ClinicalTrials.gov ID
- NCT07031050
- Acronym / sponsor ID
- SPARO / 2024-03
- Conditions
- Sacrocolpopexy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Distalmotion SAIndustry (pharma, biotech, devices)
- Collaborators
- Confinis
- Study start
- 19 May 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing a sacrocolpopexy or sacrocervicopexy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacrocolpopexy or sacrocervicopexyRobotic-assisted sacrocolpopexy or sacrocervicopexy with the Dexter robotic surgery system | Device | – |
Primary outcome
Primary safety outcome
Time frame: up to 42 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
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LAparoscopic Preventive PRErectal Mesh
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacrocolpopexy, run by Distalmotion SA at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety outcome (time frame: up to 42 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.