By InvitationNot Applicable

i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

Germany100 participantsStarted 2025-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Surgery for POP * SSLF with usage of i-Stitch device (\& i-Stitch Loading Units) * Concomitant procedures are allowed * Women minimum 18 years old * Written informed consent for surgery Exclusion Criteria: * infection (active or latent) * allergies to the materials used * benign or malignant changes * anticoagulation disorders * autoimmune connective tissue disorders * any uterus pathologies

What they're measuring

Subjective outcome

Timeframe: 12 months

Subjective outcome

Timeframe: 3 months

Trial details

NCT IDNCT06805006

SponsorA.M.I. Agency for Medical Innovations GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-07-30

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials