NCT06805006

i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: A.M.I. Agency for Medical Innovations GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The i-Stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. It is used together with the i-Stitch loading units. The use of i-Stitch for the fixation of surgical urogynaecological mesh implants (e.g. BSC Mesh, InGYNious) has already been proven in several studies. The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.

Conditions

• Pelvic Organ Prolapse
• Genital Prolapse

Interventions

Type	Name	Description
DEVICE	SSLF	Bilateral sacrospinous ligament fixation with i-Stitch device

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-07-30
• Completion: 2026-10-31
• First posted: 2025-02-03
• Last updated: 2026-03-20

Locations

1 site across 1 country: Germany