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RECRUITING
NCT05836844

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

View on ClinicalTrials.gov

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

DEVICE

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