Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT03516136
• Lead Sponsor: Allium, Ltd.

Brief Summary

A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-04
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-05-04
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

1. Female subjects >18 years old that underwent Pelvic Organ Prolapse repair utilizing the EndoFast Reliant SCP

Exclusion Criteria

1. Patients without follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety- procedure and device related complication rate	Up to 4 years	Percentage of device and procedure related complications.