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Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Enrollment target: estimated 200 to confirmed 196
    • Primary completion date changed from estimate of Aug 31, 2025 to Sep 23, 2025
    • Start date: Aug 4, 2022 to Jun 30, 2022
    • Site details revised at 9 of 9 sites
  2. Primary completion date: Oct 30, 2024 to Aug 31, 2025
    • Study completion date: Oct 31, 2028 to Sep 30, 2029
    • Eligibility criteria expanded, about 51 words
    • Site details revised at 7 of 9 sites
    v5
  3. Study sites: 3 to 9
    • Primary completion date: Jun 30, 2024 to Oct 30, 2024
    • Study completion date: Jul 31, 2028 to Oct 31, 2028
    v4
  4. Trial status: Active, Not Recruiting to Recruiting
    • Start date: Jun 20, 2022 to Aug 4, 2022
    • Site details revised at 3 of 3 sites
    v3
  5. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of May 31, 2022 to Jun 20, 2022
    • Eligibility criteria expanded, about 3 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.
Trial Details
NCT Number NCT05306496
Lead Sponsor Cousin Biotech
Conditions
(from sponsor)		 Inguinal Hernia, Femoral Hernia
Related terms Hernia, Femoral, Hernia, Inguinal
Enrollment 196 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov