TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

78 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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);

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (5)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

5 locations

Study team and timeline

Lead sponsor

Tissium

Study start

Jul 4, 2023 Actual

Primary completion

Jul 4, 2026 Actual

Study completion

Oct 30, 2026 Actual

First posted

Sep 18, 2023 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.