NCT05306496

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

Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap): Assessing Hernia Recurrence and Pain up to 5-years Follow-up

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Cousin Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernia
• Femoral Hernia

Interventions

Type	Name	Description
DEVICE	Pre-shaped 4DMESH®	The 4DMESH® mesh is semi-resorbable parietal reinforcement implant made of 25% Polypropylene (non-resorbable) and 75% Poly-L-Lactic Acid (resorbable). 4DMESH® meshes are designed for the repair and reinforcement of inguinal and femoral hernias. 4DMesh is a CE-marked, class III medical device manufactured by Cousin Biotech.

Timeline

• Start date: 2022-06-30
• Primary completion: 2025-09-23
• Completion: 2029-09-30
• First posted: 2022-04-01
• Last updated: 2026-04-17

Locations

9 sites across 3 countries: Belgium, France, Spain