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New mesh aims to cut hernia recurrence in 5-Year trial

NCT ID NCT05306496

Disease control Sponsor: Cousin Biotech Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a special mesh called 4DMESH® used in laparoscopic hernia repair. The goal is to see if it helps prevent hernias from coming back and reduces pain over 5 years. About 196 adults with a first-time inguinal or femoral hernia will take part. Researchers will track recovery, quality of life, and any complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

196 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Hernia, Femoral Hernia, Inguinal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Femoral hernia Inguinal hernia

Contacts and locations

Locations

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500, Belgium

  • CH de Tourcoing

    Tourcoing, 59208, France

  • CHU de Nantes

    Nantes, 44093, France

  • CHU de Reims

    Reims, 51092, France

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Viamed Santa Ángela de la Cruz en Sevilla

    Seville, 41014, Spain

  • Hôpital Lyon Sud, Hospices Civils de Lyon

    Lyon, 69002, France

  • Regionaal Ziekenhuis Heilig Hart Tienen

    Tienen, Vlaams-Brabant, 3300, Belgium

  • Ziekenhuis Oost-Limburg Genk

    Genk, Limburg, 3600, Belgium

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