Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Hernia recurrence — At 12-months follow-up
To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Ziekenhuis Oost-Limburg Genk | Genk | Limburg | |
| Regionaal Ziekenhuis Heilig Hart Tienen | Tienen | Vlaams-Brabant | |
| AZ Groeninge | Kortrijk | West-Vlaanderen | |
| Hôpital Lyon Sud, Hospices Civils de Lyon | Lyon | France | |
| CHU de Nantes | Nantes | France | |
| CHU de Reims | Reims | France | |
| CH de Tourcoing | Tourcoing | France | |
| Hospital Universitario Virgen Macarena | Seville | Spain | |
| Hospital Viamed Santa Ángela de la Cruz en Sevilla | Seville | Spain |
More Cousin Biotech trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05306496 on ClinicalTrials.gov ↗ ← All trials in France