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Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse

NCT02123992 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2016-09-07

No results posted yet for this study

Summary

The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Elevate Apical and Posterior

PROCEDURE

Native Tissue Repair for pelvic organ prolapse

Sponsors & Collaborators

  • ASTORA Women's Health

    lead INDUSTRY

Principal Investigators

  • Eric R Sokol, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2019-04-30
Completion
2019-04-30

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 NCT02123992 on ClinicalTrials.gov