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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

Study acronym: i-StitchSSLF
StatusEnrolling by Invitation
PhaseNot specified
Started
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.

Record History

  1. Primary completion date: Sep 30, 2025 to Jul 30, 2026
    • Study completion date: Oct 31, 2025 to Oct 31, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06805006
Lead Sponsor A.M.I. Agency for Medical Innovations GmbH
Conditions
(from sponsor)		 Pelvic Organ Prolapse, Genital Prolapse
Related terms Pelvic Organ Prolapse
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov