TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

Launched by TISSIUM · Sep 14, 2023

Keywords

ClinConnect Summary

The TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study is researching a new method for repairing hernias, which are bulges that can occur in the abdomen. This study aims to gather early information about how safe and effective the TAHRS system is for patients who need laparoscopic (a minimally invasive) surgery to fix their hernias. If you're an adult aged 18 or older and have a specific type of hernia, such as a midline primary ventral, umbilical, or incisional hernia, you may be eligible to participate.

Participants in this trial will undergo the laparoscopic hernia repair using the TAHRS system. To join, you should be willing to sign a consent form and meet certain health criteria, like not having a high body mass index (BMI) or any severe health issues that could complicate the surgery. The study is currently looking for participants, and it's an opportunity to help advance medical knowledge while potentially benefiting from a new treatment approach. If you have questions about your eligibility or would like more details, discussing with your doctor is a great first step.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Subject is 18 years old or older;
• • 2. Patient willing and able to provide a signed Patient Informed Consent Form;
• • 3. Has a midline primary ventral, umbilical or incisional hernia;
• • 4. Scheduled for a laparoscopic IPOM hernia repair;
• • 5. Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect
• Key Exclusion Criteria:
• • 1. Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
• • 2. BMI \> 40;
• • 3. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
• • 4. Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
• • 5. Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
• • 6. Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
• • 7. Patient has more than one hernia defect (to be confirmed intraoperatively);