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Clinical Investigation to Evaluate Safety and Performance of the EndoFast Reliant™ System in Vaginal Wall Reinforcement

NCT00446693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-11-19

No results posted yet for this study

Summary

The purpose of this study is to clinically assess the safety and performance of the EndoFast Reliant™ system as a less invasive treatment for Pelvic Organ Prolapse.

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

EndoFast Reliant™ system for Pelvic Organ Prolapse repair

The EndoFast Reliant™ system is a new concept of reinforcing the vaginal wall with proprietary mesh and soft-tissue Fasteners in a minimally-invasive procedure.

Sponsors & Collaborators

  • Endogun Medical Systems Ltd.

    lead INDUSTRY

Principal Investigators

  • Peter Von Theobald, Prof. · Professeur d'Université-Praticien Hospitalier, gynécologie

  • Michel Cosson, Prof. · Hôpital Jeanne de Flandre - CHRU Gynécologie obstétrique

  • Genadi Bitman, MD · Sheba Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-06-30
Completion
2009-06-30

Countries

  • France
  • 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 NCT00446693 on ClinicalTrials.gov