TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study


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


  • 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

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