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Pragmatic Evaluation of Performance and Safety of the Anchorsure® Transvaginal Device for Surgical Treatment of Apical Prolapse in Women

NCT05836844 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Prolapse; Female
  • Prolapse Uterovaginal
  • Prolapse; Cervix

Interventions

DEVICE

The Anchorsure System®

Sacrospinous ligament fixation performed with the Anchorsure Device

Sponsors & Collaborators

  • University Hospital, Lille

    collaborator OTHER

  • Kremlin-Bicetre Hospital, Paris

    collaborator UNKNOWN

  • Clinique Sainte-Anne, Strasbourg

    collaborator UNKNOWN

  • Centre Hospitalier de La Rochelle

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2024-10-01
Completion
2028-06-01
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05836844 on ClinicalTrials.gov