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

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ClinicalTrials.gov Identifier: NCT00446693
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : November 19, 2009
Sponsor:
Information provided by:
Endogun Medical Systems Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Device: EndoFast Reliant™ system for Pelvic Organ Prolapse repair Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Safety is defined as paucity of major device-related complications. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

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