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Clinical Trials in Germany / NCT06805006
Enrolling by invitation Observational

i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

NCT06805006 · tracked via the Priya Life Science Germany tracker
Sponsor
A.M.I. Agency for Medical Innovations GmbH
Phase
Observational
Started
2025-01-01
Last updated
2026-03-20

Condition(s) studied

Pelvic Organ ProlapseGenital Prolapse

Investigational drug(s) / intervention(s)

SSLF

SSLF: Bilateral sacrospinous ligament fixation with i-Stitch device

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Isar Kliniken GmbH Munich Bavaria

More A.M.I. Agency for Medical Innovations GmbH trials in Germany

Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious) Recruiting
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI) Active, not recruiting
Retrospective Data Analysis PelviGYNious/EndoGYNious Active, not recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious) Starting soon

Other trials for the same condition

Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious) Recruiting
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry Recruiting
Post-market Clinical Follow-up of the SRS Implant Active, not recruiting
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse Recruiting
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06805006 on ClinicalTrials.gov ↗ ← All trials in Germany