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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

NCT06805006 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-20

No results posted yet for this study

Summary

The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.

Conditions

  • Pelvic Organ Prolapse
  • Genital Prolapse

Interventions

DEVICE

SSLF

Bilateral sacrospinous ligament fixation with i-Stitch device

Sponsors & Collaborators

  • A.M.I. Agency for Medical Innovations GmbH

    lead INDUSTRY

Principal Investigators

  • Ursula Peschers, Prof. Dr. · ISAR Klinikum Munich

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-07-30
Completion
2026-10-31

Countries

  • Germany

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 NCT06805006 on ClinicalTrials.gov