Status:
COMPLETED
Clinical Investigation to Evaluate Safety and Performance of the EndoFast Reliant™ System in Vaginal Wall Reinforcement
Lead Sponsor:
Endogun Medical Systems Ltd.
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
40-80 years
Phase:
NA
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.
Detailed Description
Background: Pelvic Organ Prolapse represents a significant problem worldwide and may have a significant negative impact on a woman's quality of life. The uterus, rectum and the bladder are held in th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00446693
Start Date
February 1 2007
End Date
June 1 2009
Last Update
November 19 2009
Active Locations (3)
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1
CHU de Caen
Caen, France, 14033
2
Hôpital Jeanne de Flandre - CHRU Gynécologie obstétrique
Lille, France, 56037
3
Sheba Medical Center
Ramat Gan, Israel, 52621