Atraumatic hernia repair using TISSIUM™ system

ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Atraumatic Hernia Repair System (TAHRS) for Laparoscopic Hernia Repair

This study is testing a new hernia repair system to see if it safely and effectively helps people with certain types of hernias during laparoscopic surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tissium (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Genk, Limburg and 4 other locations)
• Trial ID: NCT06042205 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a midline primary ventral, umbilical, or incisional hernia scheduled for laparoscopic repair.

Not a fit: Patients with a BMI over 40, known hypersensitivity to the device materials, or those with multiple hernia defects may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective method for hernia repair, potentially reducing recovery time and complications.

How similar studies have performed: While this study explores a novel approach, similar interventions in hernia repair have shown promise in improving outcomes.

Eligibility criteria

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 this trial is running

Genk, Limburg and 4 other locations

• Ziekenhuis Oost-Limburg [ZOL] — Genk, Limburg, Belgium (Recruiting)
• Imelda Hospital — Bonheiden, Belgium (Recruiting)
• AZ Sint-Jan — Ruddershove, Belgium (Active_not_recruiting)
• CHU UCL Namur — Yvoir, Belgium (Recruiting)
• Universitary Hospital Virgen Macarena — Seville, Spain (Recruiting)

Study contacts

• Study coordinator: Sr. Manager, Clinical Affairs

Conditions Hernia