RecruitingNCT04829175

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse


Sponsor

Ethicon, Inc.

Enrollment

1,000 participants

Start Date

Apr 11, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.


Eligibility

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Intervention for people with stress urinary incontinence and pelvic organ prolapse. The study is currently recruiting participants at 10 locations. People eligible for this study include women aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntervention

There is no intervention, beyond necessary clinical care, in this registry. The surgical procedures being performed within the registry are identical to the surgical procedures patients would receive as part of SOC.


Locations(10)

Yale University

New Haven, Connecticut, United States

Duke University

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Krankenhaus der barmherzigen Schwestern

Linz, Austria

Herlev Hospital

Hillerød, Denmark

Hopital Jeanne de Flandres

Lille, France

Universitatsklinikum Tubingen

Tübingen, Germany

Bio-Medical University Rome

Rome, Italy

Karolinska Institute

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

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NCT04829175


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