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ENROLLING BY INVITATION
NCT06805006
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Sponsor: A.M.I. Agency for Medical Innovations GmbH
View on ClinicalTrials.gov
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-01-01
Completion Date
2026-10-31
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
DEVICE
SSLF
Bilateral sacrospinous ligament fixation with i-Stitch device
Locations (1)
Isar Kliniken GmbH
Munich, Bavaria, Germany