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Post-Market Clinical Follow-Up onTVT EXACT® Continence System

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 63 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv62-v63
  2. Primary completion moved earlier from Sep 30, 2035 to Sep 30, 2030
    • Study completion moved earlier from Feb 28, 2036 to Sep 30, 2035
    • Start date: Jul 8, 2021 to Jul 7, 2021
    v61
  3. Primary completion pushed from Sep 30, 2030 to Sep 30, 2035
    • Study completion pushed from Sep 30, 2035 to Feb 28, 2036
    • Start date: Jul 7, 2021 to Jul 8, 2021
    v60
  4. Primary completion date: Sep 30, 2035 to Sep 30, 2030
    • Study completion date: Feb 28, 2036 to Sep 30, 2035
    v59
  5. Start date: Jul 8, 2021 to Jul 7, 2021v58
Show 44 earlier versionsHide 44 earlier versions
  1. 6 versions Re-verified since Aug 14, 2025, no change to tracked fieldsv52-v57
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 195 to confirmed 198
    • Site details revised at 8 of 8 sites
    v51
  3. 2 versions Re-verified since Apr 24, 2025, no change to tracked fieldsv49-v50
  4. Site details revised at 3 of 8 sitesv48
  5. 7 versions Re-verified since Aug 12, 2024, no change to tracked fieldsv41-v47
  6. Primary completion date: Sep 30, 2034 to Sep 30, 2035
    • Study completion date: Feb 27, 2035 to Feb 28, 2036
    v40
  7. 12 versions Re-verified since Jul 18, 2023, no change to tracked fieldsv28-v39
  8. Primary completion date: Sep 30, 2032 to Sep 30, 2034
    • Study completion date: Feb 27, 2033 to Feb 27, 2035
    • Site details revised at 4 of 8 sites
    v27
  9. 6 versions Re-verified since Dec 27, 2022, no change to tracked fieldsv21-v26
  10. Study sites: 7 to 8v20
  11. 6 versions Re-verified since May 16, 2022, no change to tracked fieldsv14-v19
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ethicon, Inc.
9 trials monitored
See 1 trial at risk
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).
Trial Details
NCT Number NCT04829994
Lead Sponsor Ethicon, Inc.
Conditions
(from sponsor)		 Stress Urinary Incontinence
Related terms Urinary Incontinence, Stress
Enrollment 198 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov