Status:
ACTIVE_NOT_RECRUITING
TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
Lead Sponsor:
Tissium
Conditions:
Hernia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
Eligibility Criteria
Inclusion
- Key
- Subject is 18 years old or older;
- Patient willing and able to provide a signed Patient Informed Consent Form;
- Has a midline primary ventral, umbilical or incisional hernia;
- Scheduled for a laparoscopic IPOM hernia repair;
- Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect
- Key
Exclusion
- Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
- BMI \> 40;
- Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
- Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
- Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
- Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
- Patient has more than one hernia defect (to be confirmed intraoperatively);
Key Trial Info
Start Date :
July 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06042205
Start Date
July 4 2023
End Date
July 4 2026
Last Update
July 16 2025
Active Locations (5)
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1
Ziekenhuis Oost-Limburg [ZOL]
Genk, Limburg, Belgium, 3600
2
Imelda Hospital
Bonheiden, Belgium
3
AZ Sint-Jan
Ruddershove, Belgium
4
CHU UCL Namur
Yvoir, Belgium, 5530