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

NCT ID: NCT03516136

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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EndoFast Reliant SCP

POP repair procedure with the EndoFast Reliant SCP system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Allium, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CL-SCP-60-04-R

Identifier Type: -

Identifier Source: org_study_id

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