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The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse

NCT03436979 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-08-07

No results posted yet for this study

Summary

The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.

Conditions

  • Uterine Prolapse Without Vaginal Wall Prolapse

Interventions

DEVICE

NeuGuide™ System

The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.

Sponsors & Collaborators

  • Pop Medical Solutions

    lead INDUSTRY

Principal Investigators

  • James C Leiter, M.D. · Avania

Eligibility

Min Age
36 Years
Max Age
84 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States
  • Germany
  • Israel

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 NCT03436979 on ClinicalTrials.gov