Evaluation of the Anchorsure® Device for Treating Apical Prolapse in Women
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.
This study is testing a new device called Anchorsure® to see if it can help women with pelvic organ prolapse have a quicker and less painful surgery while keeping everything securely in place.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 4 sites (La Rochelle and 3 other locations) |
| Trial ID | NCT05836844 on ClinicalTrials.gov |
What this trial studies
This observational cohort study evaluates the performance and safety of the Anchorsure® transvaginal device in women undergoing surgical treatment for apical prolapse. The study focuses on patients with pelvic organ prolapse who are scheduled for sacrospinous fixation using the Anchorsure® system. Participants will be followed for 36 months to assess the effectiveness of the device in reducing operative time and postoperative pain while ensuring strong fixation. The primary objective is to determine the device's performance one year after surgery in real-life settings.
Who should consider this trial
Good fit: Ideal candidates are women with pelvic organ prolapse requiring surgical intervention using the Anchorsure® system.
Not a fit: Patients not undergoing apical suspension or those involved in other interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced postoperative pain for women with apical prolapse.
How similar studies have performed: Other studies have explored similar surgical interventions, but the specific use of the Anchorsure® device in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with pelvic organ prolapse with leading edge at or beyond the hymen as confirmed by the pelvic organ prolapse quantification system (POP-Q), i.e. Ba ≥ -1 cm for the anterior compartment, and/or Bp ≥ -1 cm for the posterior compartment, and/or C ≥ -1 cm for the apical compartment including recurrence. * Women due for POP surgery using the Anchorsure System® for apical prolapse suspension with or without concomitant native tissue repair, with or without concomitant hysterectomy and with or without concomitant sling for stress urinary incontinence. * All women who have not indicated any objection to participating in the study. * All women who have been correctly informed. Exclusion Criteria: * Patient taking part or having taken part in a device or drug interventional study within the last three months (except for VIGI-MESH national registry). * Patients due for pelvic organ prolapse repair without apical suspension or with anything other than native tissue repair and the Anchorsure System®. * Patients with uncontrolled diabetes mellitus. * Patients with active non-controlled or chronic gynaecologic or urinary tract infection and/or local tissue necrosis. * Patients with ongoing pelvic organ cancer (e.g. uterine, ovarian, bladder, cervix …). * Patients with a history of radiotherapy in the pelvic area. * Patients on therapy with immunosuppressive or immunomodulatory treatment within the previous month. * patients under ongoing oral anticoagulant therapy. * Patients with stage 0 and 1 pelvic organ prolapse at the time of surgery * Patients with a preoperative infection contraindicating the surgery
Where this trial is running
La Rochelle and 3 other locations
- 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)
Study contacts
- Study coordinator: Renaud de TAYRAC, Professor
- Email: renaud.detayrac@chu-nimes.fr
- Phone: +334 66 68 32 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.