TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

NCT06042205 | Active Not Recruiting

• 1 other identifier: PF00006-CLPR-002
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of hernia recurrence through 12 months post- surgery

  through 12 months post-surgery

Study Arms (1)

Hernia repair

EXPERIMENTAL

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)

Device: TISSIUM™ Atraumatic Hernia Repair System (TAHRS)

Interventions

TISSIUM™ Atraumatic Hernia Repair System (TAHRS) DEVICE

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

Hernia repair

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years old or older;
• Patient willing and able to provide a signed Patient Informed Consent Form;
• Has a midline primary ventral, umbilical or incisional hernia;
• Scheduled for a laparoscopic IPOM hernia repair;
• Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect

You may not qualify if:

• Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
• BMI \> 40;
• Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
• Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
• Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
• Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
• Patient has more than one hernia defect (to be confirmed intraoperatively);

Sponsors & Collaborators

• Tissium: lead

Study Sites (5)

Ziekenhuis Oost-Limburg [ZOL]

Genk, Limburg, 3600, Belgium

Location

Imelda Hospital

Bonheiden, Belgium

Location

AZ Sint-Jan

Ruddershove, Belgium

Location

CHU UCL Namur

Yvoir, 5530, Belgium

Location

Universitary Hospital Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 18, 2023
• Study Start: July 4, 2023
• Primary Completion (Estimated): July 4, 2026
• Study Completion (Estimated): July 4, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); BE (4)