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RECRUITING
NCT05306496
NA

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

Sponsor: Cousin Biotech

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2022-08-04

Completion Date

2029-09-30

Last Updated

2024-04-16

Healthy Volunteers

No

Interventions

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.

Locations (9)

Ziekenhuis Oost-Limburg Genk

Genk, Limburg, Belgium

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, Vlaams-Brabant, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

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