Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women
Condition(s) studied
Investigational drug(s) / intervention(s)
The Anchorsure System®: Sacrospinous ligament fixation performed with the Anchorsure Device
Study summary
Pelvic Organ Prolapse affects 50% of parous women, and apical prolapse is one of the most common types of prolapse. Treatment for apical prolapse ranges from observation, non-surgical treatment or surgical repair. An anchoring device can reduce dissection and operative time and is meant to provide strong fixation whilst minimizing potential postoperative pain by avoiding neurovascular injuries. These potential advantages must be evaluated in terms of performance and safety. This cohort study will be on patients undergoing sacrospinous fixation with the Anchorsure® system with a follow-up of 36 months.
Eligibility
Primary outcome measure(s)
- Successful performance after sacrospinous fixation of the Anchorsure System®. — 12 months after fixation
YES /NO
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| La Rochelle General Hospital | La Rochelle | France | Recruiting |
| Lille University Hospital | Lille | France | Recruiting |
| Kremlin-Bicêtre Hospital | Paris | France | Recruiting |
| Clinique Sainte-Anne | Strasbourg | France | Recruiting |
More Centre Hospitalier Universitaire de Nīmes trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05836844 on ClinicalTrials.gov ↗ ← All trials in France