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RECRUITING
NCT05042453

Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

Sponsor: Promedon

View on ClinicalTrials.gov

Summary

This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse

Official title: Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2022-12-19

Completion Date

2030-07

Last Updated

2024-11-22

Healthy Volunteers

No

Interventions

DEVICE

Splentis® POP Tissue Anchoring System

Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis

Locations (7)

DRK Hospital Chemnitz-Rabenstein

Chemnitz, Germany

Helios Hospital Erfurt, Department of gynaecology

Erfurt, Germany

University Hospital Freiburg

Freiburg im Breisgau, Germany

Clinic Kassel

Kassel, Germany

St. Elisabeth Hospital

Leipzig, Germany

University Hospital

Mannheim, Germany

Hospital Tettnang

Tettnang, Germany