Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Ethicon, Inc.
Study ID
NCT04829175
Status
Recruiting
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Conditions

  • Pelvic Organ Prolapse
  • Stress Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intervention — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 11, 2022
Status verified
Jun 2026
Primary completion
Mar 31, 2033
Completion
Mar 31, 2038

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change [ Time Frame: Post-surgery through registry completion, approximately 5-10 yrs ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510-
Duke UniversityDurhamNorth Carolina27707-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
UPMCPittsburghPennsylvania15213-

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By research site
Yale University· New Haven, CTDuke University· Durham, NCUniversity of Pennsylvania· Philadelphia, PAUPMC· Pittsburgh, PA

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