Clinical Trial

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

Active, Not Recruiting
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-03-23; most recent amendment 2026-04-14.
Status change: Recruiting → Active, Not Recruiting 2026-04-14
Status change: Active, Not Recruiting → Recruiting 2022-09-15
Status change: Not Yet Recruiting → Active, Not Recruiting 2022-06-23
Trial Details
NCT Number NCT05306496
Lead Sponsor Cousin Biotech
Conditions Inguinal Hernia, Femoral Hernia
Enrollment 196 participants
Start Date 2022-06-30
Primary Completion 2025-09-23 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-17