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

NCT05042453 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-11-22

No results posted yet for this study

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

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Splentis® POP Tissue Anchoring System

Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis

Sponsors & Collaborators

  • Promedon

    lead INDUSTRY

Principal Investigators

  • Gert Naumann, MD · Helios Clinic Erfurt, Germany

  • Christian Fünfgeld, MD · Clinic Tettnang

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2026-07-31
Completion
2030-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05042453 on ClinicalTrials.gov