TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

NCT ID: NCT06042205

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2026-07-04

Brief Summary

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

Conditions

Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hernia repair

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)

Group Type: EXPERIMENTAL

TISSIUM™ Atraumatic Hernia Repair System (TAHRS)

Intervention Type: DEVICE

The TAHRS is intended for fixation of prosthetic material to soft tissue

Interventions

TISSIUM™ Atraumatic Hernia Repair System (TAHRS)

The TAHRS is intended for fixation of prosthetic material to soft tissue

Intervention Type: DEVICE

Eligibility Criteria

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

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tissium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ziekenhuis Oost-Limburg [ZOL]

Genk, Limburg, Belgium

Imelda Hospital

Bonheiden, , Belgium

AZ Sint-Jan

Ruddershove, , Belgium

CHU UCL Namur

Yvoir, , Belgium

Universitary Hospital Virgen Macarena

Seville, , Spain

Countries

Belgium; Spain

Other Identifiers

PF00006-CLPR-002

Identifier Type: -

Identifier Source: org_study_id