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TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

Non Recruiting
18-65 years
All
Phase N/A

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Overview

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

Eligibility

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 details
    Hernia

NCT06042205

Tissium

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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