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Flat Polypropylene Mesh in the Treatment of Uterine and Recurrent or Advanced Pelvic Organ Prolapse

NCT06225375 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-25

No results posted yet for this study

Summary

This study is being done to evaluate the safety and feasibility of using flat polypropylene Restorelle® mesh, an ultra-lightweight mesh, for transvaginal use in surgically correcting certain specific cases of pelvic organ prolapse, such as recurrent (previous failed native tissue repair), large stage III or IV pelvic organ prolapse, and those with symptomatic uterine prolapse desiring uterine-sparing surgery (called hysteropexy).

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Restorelle® Flat Mesh

Pelvic organ prolapse repair using Restorelle® Flat Mesh

Sponsors & Collaborators

  • Michigan Institution of Women's Health PC

    lead OTHER

Principal Investigators

  • Salil Khandwala, MD · Michigan Women's Institution of health PC.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-12-01
Completion
2026-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06225375 on ClinicalTrials.gov