Atraumatic hernia repair using TISSIUM™ system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the clinical safety and performance of the TISSIUM™ Atraumatic Hernia Repair System (TAHRS) in patients undergoing laparoscopic repair for midline primary ventral, umbilical, or incisional hernias. Participants will be assessed for their ability to have their hernia repaired with a specific overlap of mesh. The study will capture preliminary data on the effectiveness and safety of this innovative repair system.

Why it matters

Who can join: the full rules

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);

Where it's running

• Ziekenhuis Oost-Limburg [ZOL]
  Genk, Limburg, Belgium Recruiting
• Imelda Hospital
  Bonheiden, Belgium Recruiting
• CHU UCL Namur
  Yvoir, Belgium Recruiting
• Universitary Hospital Virgen Macarena
  Seville, Spain Recruiting
• AZ Sint-Jan
  Ruddershove, Belgium Active not recruiting

Study contacts

• Study coordinator: Sr. Manager, Clinical Affairs
• Email: ntrinward@tissium.com
• Phone: +1 857-408-0709

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Patient outcomes for hernia surgery at Shouldice Hospital

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.