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Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

NCT03681223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-01-30

Study results available
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Summary

This is a randomized clinical trial to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh for the treatment of vaginal vault prolapse.

Hypothesis: Vertessa® lite Y mesh is not inferior to Restorelle® Y mesh for the treatment of vaginal vault prolapse

Conditions

  • Vaginal Vault Prolapse

Interventions

DEVICE

Vertessa® Lite Y mesh

Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive.

DEVICE

Restorelle® Y mesh

Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive.

PROCEDURE

Laparoscopic sacrocolpopexy

The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation

PROCEDURE

Robotic assisted laparoscopic sacrocolpopexy

The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Cecile A Unger, MD, MPH · Assistant Professor of Surgery. Center for Urogynecology and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland OH

  • Marie Fidela R Paraiso, MD · Professor, Section Head of the Center for Urogynecology and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland OH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2023-12-19
Completion
2023-12-19
FDA Device
Yes

Countries

  • United States

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 NCT03681223 on ClinicalTrials.gov