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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014