NCT00446693

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

Enrollment Period

1.3 years

First QC Date

March 12, 2007

Last Update Submit

November 18, 2009

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Safety is defined as paucity of major device-related complications.

    12 months

Secondary Outcomes (1)

  • Performance as defined by relative improvement in Pelvic Organ Prolapse staging (as reported post operatively versus preoperatively) using the POPQ grading system.

    12 months

Study Arms (1)

I

EXPERIMENTAL

Use of EndoFast Reliant System

Device: EndoFast Reliant™ system for Pelvic Organ Prolapse repair

Interventions

EndoFast Reliant™ system for Pelvic Organ Prolapse repairDEVICE

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.

I

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Caen

Caen, 14033, France

Location

Hôpital Jeanne de Flandre - CHRU Gynécologie obstétrique

Lille, 56037, France

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2009

Last Updated

November 19, 2009

Record last verified: 2009-11

Locations

IL(1)FR(2)