TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study

Overview

The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS

Full Title of Study: “ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Adhesive Hernia Repair System (TAHRS) for Atraumatic Laparoscopic Hernia Repair”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 27, 2024

Interventions

• Device: TISSIUM™ Adhesive Hernia Repair System (TAHRS)
  • The TAHRS is intended for fixation of prosthetic material to soft tissue

Arms, Groups and Cohorts

• 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)

Clinical Trial Outcome Measures

Primary Measures

• Serious Adverse Device Effect (SADEs)
  • Time Frame: 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 Measures

• Rate of hernia recurrence through 12 months post- surgery
  • Time Frame: through 12 months post-surgery

Participating in This Clinical Trial

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 > 35; 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);

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Tissium
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Contact(s)
  • Sr. Manager, Clinical Affairs, +1 603-630-2241, ntrinward@tissium.com