TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot 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

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

Study Overview

• Status: Recruiting
• Conditions: Hernia
• Intervention / Treatment: Device: TISSIUM™ Adhesive Hernia Repair System (TAHRS)

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sr. Manager, Clinical Affairs; Phone Number: +1 857-408-0709; Email: ntrinward@tissium.com

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • Imelda Hospital
    • Principal Investigator: Tollens
  • Ruddershove, Belgium
    • Active, not recruiting
    • AZ Sint-Jan
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg [ZOL]
      • Principal Investigator: Kurt Van Der Speeten

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Device: TISSIUM™ Adhesive Hernia Repair System (TAHRS); The TAHRS is intended for fixation of prosthetic material to soft tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Device Effect (SADEs)	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,	through 12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of hernia recurrence through 12 months post- surgery	through 12 months post-surgery

Collaborators and Investigators

• Sponsor: Tissium

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Estimated): March 28, 2025
• Study Completion (Estimated): March 28, 2025

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: PF00006-CLPR-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No