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Pragmatic Evaluation of the Performance and Safety of the Anchorsure ae Transvaginal Device for Surgical Treatment of Apical Prolapse in Women A Post-market Multicentre Prospective Observational Cohort Study
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-11-17
120
Participants Needed
4
Research Sites
191 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 half of women who have given birth, with apical prolapse being a common type. This research focuses on evaluating the performance and safety of the Anchorsure ae transvaginal device used in sacrospinous fixation surgery for women with apical prolapse. The study is observational and follows patients for 36 months to assess real-life outcomes. Participants will undergo sacrospinous ligament fixation using the Anchorsure ae device. This anchoring device aims to reduce surgical dissection and operative time while providing strong fixation and minimizing postoperative pain by avoiding nerve and blood vessel injuries. The study includes follow-up assessments at various time points, including 12 months and up to 36 months after surgery. During the study, women will be monitored through clinical examinations, pain scoring from day 0 to day 30, and evaluations of device-related events and complications up to 36 months. Researchers will also assess quality of life using specific questionnaires and track patient satisfaction and the need for any surgical revisions. The primary outcome is the successful performance of the device 12 months after surgery, with ongoing safety and effectiveness assessments throughout the follow-up period.
CONDITIONS
Brief 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 as confirmed by the pelvic organ prolapse quantification system
- Women scheduled for pelvic organ prolapse surgery using the Anchorsure�ae System for apical prolapse suspension
- Women may have concomitant native tissue repair, hysterectomy, or sling for stress urinary incontinence
- Women who have been properly informed and have not objected to participation
You will not qualify if you...
- Participation in another device or drug interventional study within the last three months (except VIGI-MESH registry)
- Patients undergoing prolapse repair without apical suspension or using other than native tissue repair and Anchorsure�ae
- Uncontrolled diabetes mellitus
- Active uncontrolled or chronic gynecologic or urinary tract infection or local tissue necrosis
- Ongoing pelvic organ cancer such as uterine, ovarian, bladder, or cervix cancer
- History of pelvic area radiotherapy
- Immunosuppressive or immunomodulatory treatment in the previous month
- Ongoing oral anticoagulant therapy
- Stage 0 or 1 pelvic organ prolapse at surgery
- Preoperative infection contraindicating surgery
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo sacrospinous ligament fixation using the Anchorsure® device to surgically treat apical prolapse. Immediate post-operative monitoring occurs to assess recovery and early safety.
1 visit (in-person)
Duration - Up to 36 months after surgery
Participants are monitored for device performance, safety, and recovery outcomes including pain, adverse events, and quality of life over time after surgery.
Approximately 12 follow-up visits over 36 months
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
A
Anissa MEGZARI
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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