TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
Not Applicable
Recruiting
- Conditions
- Hernia
- Interventions
- Device: TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
- Registration Number
- NCT06042205
- Lead Sponsor
- Tissium
- Brief Summary
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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 > 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hernia repair TISSIUM™ Atraumatic Hernia Repair System (TAHRS) There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
- Primary Outcome Measures
Name Time Method Serious Adverse Device Effect (SADEs) through 12 months post-surgery Cumulative incidence of complications (CIC) related to the TAHRS including:
Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,
- Secondary Outcome Measures
Name Time Method Rate of hernia recurrence through 12 months post- surgery through 12 months post-surgery
Trial Locations
- Locations (5)
Universitary Hospital Virgen Macarena
🇪🇸Seville, Spain
Ziekenhuis Oost-Limburg [ZOL]
🇧🇪Genk, Limburg, Belgium
Imelda Hospital
🇧🇪Bonheiden, Belgium
AZ Sint-Jan
🇧🇪Ruddershove, Belgium
CHU UCL Namur
🇧🇪Yvoir, Belgium