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

This study has been completed.
Sponsor:
Information provided by:
Endogun Medical Systems Ltd.
ClinicalTrials.gov Identifier:
NCT00446693
First received: March 12, 2007
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Device: EndoFast Reliant™ system for Pelvic Organ Prolapse repair

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Multi-center, Prospective Clinical Investigation to Evaluate Safety and Performance of the EndoFast Reliant™ System in Vaginal Wall Reinforcement

Resource links provided by NLM:


Further study details as provided by Endogun Medical Systems Ltd.:

Primary Outcome Measures:
  • Safety is defined as paucity of major device-related complications. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Performance as defined by relative improvement in Pelvic Organ Prolapse staging (as reported post operatively versus preoperatively) using the POPQ grading system. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2007
Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Use of EndoFast Reliant System
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female aged between 40-80 years (inclusive) who is not pregnant or planning to have further births.
  • Subject suffers from Pelvic Organ Prolapse confirmed by vaginal inspection.
  • Patient under reliable form of contraceptive measure or menopausal.
  • Subject able to comprehend procedure and has signed Informed Consent Form for participation in this study.
  • Subject able to complete the applicable questionnaires.

Exclusion Criteria:

  • Planned to undergo hysterectomy.
  • Uterine prolapse equal to or greater than 3rd degree.
  • Documented Stress Urinary Incontinence on physical examination with full bladder or during complete urodynamic assessment with and without prolapse reduction.
  • Any chronic active and uncontrolled disease.
  • Vaginal bleeding disorders.
  • Needing emergency surgery.
  • Any acute disease.
  • Blood clotting disorders and/or anticoagulant treatment.
  • Known cognitive or psychiatric disorder.
  • High operative risk.
  • Any ongoing malignant disease.
  • Concurrent participation in any other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446693

Locations
France
CHU de Caen
Caen, France, 14033
Hôpital Jeanne de Flandre - CHRU Gynécologie obstétrique
Lille, France, 56037
Israel
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Endogun Medical Systems Ltd.
Investigators
Principal Investigator: Peter Von Theobald, Prof. Professeur d'Université-Praticien Hospitalier, gynécologie
Principal Investigator: Michel Cosson, Prof. Hôpital Jeanne de Flandre - CHRU Gynécologie obstétrique
Principal Investigator: Genadi Bitman, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Miron Livneh VP Clinical and Medical affairs, Endogun Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT00446693     History of Changes
Other Study ID Numbers: EFPS01
Study First Received: March 12, 2007
Last Updated: November 18, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 21, 2014