Ireland
--:--IST
Active, not recruiting Not applicable

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

NCT05306496 · tracked via the Priya Life Science Spain tracker
Sponsor
Cousin Biotech
Phase
Not applicable
Started
2022-06-30
Last updated
2026-04-17

Condition(s) studied

Inguinal HerniaFemoral Hernia

Investigational drug(s) / intervention(s)

Pre-shaped 4DMESH®

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient has a primary unilateral or primary bilateral inguinal or femoral hernia eligible for (robot-assisted) laparoscopic TEP or TAPP repair. 2. Patients with American Society of Anesthesiologists (ASA) grade I to III. 3. Patient ≥ 18 years of age at study entry. 4. Patient and investigator signed and dated the informed consent form prior to the index-procedure. Exclusion Criteria: 1. Patient has a recurrent inguinal or femoral hernia. 2. Patient is treated using the Lichtenstein technique. 3. Patients with ASA grade IV and V. 4. Patient is allergic to the components of the 4DMESH®. 5. Presence of an infected site. 6. Patient has a life expectancy of less than 5 years. 7. Patient is unable / unwilling to provide informed consent. 8. Patient is unable to comply with the protocol or proposed follow-up visits. 9. Patient is enrolled in another study (BE/ES) / Participation in a clinical trial within 3 months prior to the initial visit (FR). 10. Patient is pregnant (BE/FR) / Pregnant women (ES). 11. Patient benefiting from a legal protection measure (minors, under guardianship, curatorship, safeguard of justice, future protection mandate or family empowerment) (FR). 12. Patient not benefiting from a social protection scheme (FR).

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)

FacilityCityRegionStatus
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
Official registry record

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 Spain