NCT05306496

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
3 countries

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jun 2022Sep 2029

First Submitted

Initial submission to the registry

February 24, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Expected
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

February 24, 2022

Last Update Submit

April 14, 2026

Conditions

Inguinal HerniaFemoral Hernia

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence

    To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit.

    At 12-months follow-up

Secondary Outcomes (44)

  • Technical success

    At index-procedure

  • Duration of surgery

    At index-procedure

  • Duration of hospital stay

    At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day

  • Peri- and post-operative complications related to 4DMESH®

    At 5-years follow-up

  • Early recurrences

    At 4-5 weeks follow-up

  • +39 more secondary outcomes

Interventions

Pre-shaped 4DMESH®DEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has a primary unilateral or primary bilateral inguinal or femoral hernia eligible for (robot-assisted) laparoscopic TEP or TAPP repair.
  • Patients with American Society of Anesthesiologists (ASA) grade I to III.
  • Patient ≥ 18 years of age at study entry.
  • Patient and investigator signed and dated the informed consent form prior to the index-procedure.

You may not qualify if:

  • Patient has a recurrent inguinal or femoral hernia.
  • Patient is treated using the Lichtenstein technique.
  • Patients with ASA grade IV and V.
  • Patient is allergic to the components of the 4DMESH®.
  • Presence of an infected site.
  • Patient has a life expectancy of less than 5 years.
  • Patient is unable / unwilling to provide informed consent.
  • Patient is unable to comply with the protocol or proposed follow-up visits.
  • Patient is enrolled in another study (BE/ES) / Participation in a clinical trial within 3 months prior to the initial visit (FR).
  • Patient is pregnant (BE/FR) / Pregnant women (ES).
  • Patient benefiting from a legal protection measure (minors, under guardianship, curatorship, safeguard of justice, future protection mandate or family empowerment) (FR).
  • Patient not benefiting from a social protection scheme (FR).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Ziekenhuis Oost-Limburg Genk

Genk, Limburg, 3600, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, Vlaams-Brabant, 3300, Belgium

Location

AZ Groeninge

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

Hôpital Lyon Sud, Hospices Civils de Lyon

Lyon, 69002, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Reims

Reims, 51092, France

Location

CH de Tourcoing

Tourcoing, 59208, France

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Viamed Santa Ángela de la Cruz en Sevilla

Seville, 41014, Spain

Location

MeSH Terms

Conditions

Hernia, InguinalHernia, Femoral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2022

First Posted

April 1, 2022

Study Start

June 30, 2022

Primary Completion

September 23, 2025

Study Completion (Estimated)

September 30, 2029

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)BE(3)FR(4)