TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study
Hernia
About this trial
This is an interventional treatment trial for Hernia
Eligibility Criteria
Key Inclusion Criteria: 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 Criteria: Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures); BMI > 35; 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);
Sites / Locations
- Imelda HospitalRecruiting
- AZ Sint-JanRecruiting
Arms of the Study
Arm 1
Experimental
Hernia repair
There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Adhesive Hernia Repair System (TAHRS)