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NCT03516136 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

Official title:
A Retrospective Study for Collecting Data on the Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03516136
Other study ID # CL-SCP-60-04-R
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date December 31, 2017

Study information
Verified date April 2018
Source Allium, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• EndoFast Reliant SCP
POP repair procedure with the EndoFast Reliant SCP system

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allium, Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Safety- procedure and device related complication rate Percentage of device and procedure related complications. Up to 4 years
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