TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

Tissium

Status: Active, not recruiting

Conditions: Hernia

Treatments: Device: TISSIUM™ Atraumatic Hernia Repair System (TAHRS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06042205

PF00006-CLPR-002

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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);

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Hernia repair

Experimental group

Description:

There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Atraumatic Hernia Repair System (TAHRS)

Treatment:

Device: TISSIUM™ Atraumatic Hernia Repair System (TAHRS)