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Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

NCT04829175 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence
  • Pelvic Organ Prolapse

Interventions

DEVICE

Intervention

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.

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Weisberg, MD · Ethicon, Inc.

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2033-03-31
Completion
2038-03-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Denmark
  • France
  • Germany
  • Italy
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829175 on ClinicalTrials.gov