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

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.

Completed

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients without follow-up

Treatment and study plan

EndoFast Reliant SCP

Device

POP repair procedure with the EndoFast Reliant SCP system

Primary outcomes

Safety- procedure and device related complication rate

Time frame: Up to 4 years

Percentage of device and procedure related complications.

Sponsors and collaborators

Lead sponsor

Allium, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: May 4, 2018
Registry last updated: May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed