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Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women
Sponsor: Centre Hospitalier Universitaire de Nīmes
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.
Official title: APAS Study: Pragmatic Evaluation of the Performance and Safety of the Anchorsure System® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women. A Post-market Multicentre Prospective Observational Cohort Study.
Key Details
Gender
FEMALE
Age Range
50 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2023-05-11
Completion Date
2028-06-01
Last Updated
2025-11-17
Healthy Volunteers
Not specified
Interventions
The Anchorsure System®
Sacrospinous ligament fixation performed with the Anchorsure Device
Locations (4)
La Rochelle General Hospital
La Rochelle, France
Lille University Hospital
Lille, France
Kremlin-Bicêtre Hospital
Paris, France
Clinique Sainte-Anne
Strasbourg, France