Status:
RECRUITING
Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
Lead Sponsor:
Cousin Biotech
Conditions:
Inguinal Hernia
Femoral Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
August 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05306496
Start Date
August 4 2022
End Date
September 30 2029
Last Update
April 16 2024
Active Locations (9)
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1
Ziekenhuis Oost-Limburg Genk
Genk, Limburg, Belgium, 3600
2
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Vlaams-Brabant, Belgium, 3300
3
AZ Groeninge
Kortrijk, West-Vlaanderen, Belgium, 8500
4
Hôpital Lyon Sud, Hospices Civils de Lyon
Lyon, France, 69002