Clinical Trial

i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

Study acronym: i-StitchSSLF
Enrolling by Invitation
View on ClinicalTrials.gov →
Record status
This record was last updated March 20, 2026 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-28.
Trial Details
NCT Number NCT06805006
Lead Sponsor A.M.I. Agency for Medical Innovations GmbH
Conditions Pelvic Organ Prolapse, Genital Prolapse
Enrollment 100 participants
Start Date 2025-01-01
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-20