TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

Not Applicable

Active, not recruiting

• Conditions: Hernia

• Registration Number: NCT06042205
• Lead Sponsor: Tissium

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-04
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-07-04
• Study Completion: 2026-07-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Serious Adverse Device Effect (SADEs)	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 Outcome Measures

Name	Time	Method
Rate of hernia recurrence through 12 months post- surgery	through 12 months post-surgery

Trial Locations

Locations (5)

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