Trials / Recruiting
RecruitingNCT04829357
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT ABBREVO® Continence System for the Treatment of Stress Urinary Incontinence
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 195 (estimated)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intervention | There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures the subjects would receive as part of SOC. |
Timeline
- Start date
- 2021-09-09
- Primary completion
- 2036-09-30
- Completion
- 2037-02-27
- First posted
- 2021-04-02
- Last updated
- 2026-04-13
Locations
4 sites across 3 countries: United States, Italy, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04829357. Inclusion in this directory is not an endorsement.