Trials / Active Not Recruiting
Active Not RecruitingNCT04829994
Post-Market Clinical Follow-Up onTVT EXACT® Continence System
A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 198 (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 EXACT® Continence System in women undergoing retropubic 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 subjects would receive as part of SOC. |
Timeline
- Start date
- 2021-07-08
- Primary completion
- 2035-09-30
- Completion
- 2036-02-28
- First posted
- 2021-04-02
- Last updated
- 2026-04-13
Locations
8 sites across 6 countries: United States, Austria, Denmark, France, Germany, Sweden
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04829994. Inclusion in this directory is not an endorsement.