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

NCT02121977 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 285

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® Anterior and Apical Prolapse Repair System for repair of anterior/apical pelvic organ prolapse in a controlled, post-market cohort study.

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Elevate Anterior and Apical

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 NCT02121977 on ClinicalTrials.gov