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

This study is currently recruiting participants.

Verified by Endogun Medical Systems Ltd., January 2008

Sponsored by:	Endogun Medical Systems Ltd.
Information provided by:	Endogun Medical Systems Ltd.
ClinicalTrials.gov Identifier:	NCT00446693

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

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Arm, Multi-Center, Prospective Clinical Investigation to Evaluate Safety and Performance of the EndoFast Reliant™ System in Vaginal Wall Reinforcement

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 ]

Estimated Enrollment:	20
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental 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.

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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

Contacts

Contact: Elad Naggar, CEO LLB MBA	+972-54-7776717	elad@endogun.com
Contact: Miron Livneh, MD	+972-54-7774229	miron@endogun.com

Locations

France
CHU de Caen	Recruiting
Caen, France, 14033
Contact: Peter Von Theobald, Prof. +33-2.31.27.25.33 vontheobald-p@chu-caen.fr
Principal Investigator: Peter Von Theobald, Prof.
Hôpital Jeanne de Flandre - CHRU Gynécologie obstétrique	Recruiting
Lille, France, 56037
Contact: Jean-Philippe LUCOT, Dr. +33-320 44 64 37 jplucot@chru-lille.fr
Principal Investigator: Michel Cosson, Prof.
Sub-Investigator: Jean-Philippe LUCOT, Dr.
Israel
Sheba Medical Center	Recruiting
Ramat Gan, Israel, 52621
Contact: Genadi Bitman, MD +972 (0)5478 0586
Principal Investigator: Genadi Bitman, MD

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

Responsible Party:	Endogun Medical Systems Ltd. ( Dr. Miron Livneh VP Clinical and Medical affairs )
Study ID Numbers:	EFPS01
Study First Received:	March 12, 2007
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00446693
Health Authority:	France: Afssaps - French Health Products Safety Agency; Israel: Ministry of Health

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on January 16, 2009