Ireland
--:--IST
Active, not recruiting Not applicable

TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

NCT06042205 · tracked via the Priya Life Science Spain tracker
Sponsor
Tissium
Phase
Not applicable
Started
2023-07-04
Last updated
2025-07-16

Condition(s) studied

Hernia

Investigational drug(s) / intervention(s)

TISSIUM™ Atraumatic Hernia Repair System (TAHRS)

TISSIUM™ Atraumatic Hernia Repair System (TAHRS): The TAHRS is intended for fixation of prosthetic material to soft tissue

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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);

Primary outcome measure(s)

  • 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,

Trial sites (5)

FacilityCityRegionStatus
Ziekenhuis Oost-Limburg [ZOL] Genk Limburg
Imelda Hospital Bonheiden Belgium
AZ Sint-Jan Ruddershove Belgium
CHU UCL Namur Yvoir Belgium
Universitary Hospital Virgen Macarena Seville Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06042205 on ClinicalTrials.gov ↗ ← All trials in Spain