Actively Recruiting
Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-11-17
120
Participants Needed
4
Research Sites
264 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Nīmes
Lead Sponsor
U
University Hospital, Lille
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with pelvic organ prolapse with leading edge at or beyond the hymen confirmed by pelvic organ prolapse quantification system (POP-Q)
- Women scheduled for apical prolapse surgery using the Anchorsure System® with or without native tissue repair, hysterectomy, or sling for stress urinary incontinence
- Women who have not objected to participating in the study
- Women who have been properly informed about the study
You will not qualify if you...
- Participation in another device or drug interventional study within the last three months (except VIGI-MESH national registry)
- Patients scheduled for prolapse repair without apical suspension or with other than native tissue repair and Anchorsure System®
- Patients with uncontrolled diabetes mellitus
- Patients with active uncontrolled or chronic gynecologic or urinary tract infections or local tissue necrosis
- Patients with ongoing pelvic organ cancer
- Patients with history of pelvic area radiotherapy
- Patients on immunosuppressive or immunomodulatory treatment within the previous month
- Patients under ongoing oral anticoagulant therapy
- Patients with stage 0 or 1 pelvic organ prolapse at the time of surgery
- Patients with preoperative infection contraindicating surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
La Rochelle General Hospital
La Rochelle, France, 17000
Actively Recruiting
2
Lille University Hospital
Lille, France, 59000
Actively Recruiting
3
Kremlin-Bicêtre Hospital
Paris, France, 94270
Actively Recruiting
4
Clinique Sainte-Anne
Strasbourg, France, 67000
Actively Recruiting
Research Team
R
Renaud de TAYRAC, Professor
CONTACT
A
Anissa MEGZARI
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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