TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06042205

Enrollment

Registered

2023-09-18

Start date

2023-07-04

Completion date

2026-07-04

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia

Brief summary

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

Interventions

DEVICETISSIUM™ Atraumatic Hernia Repair System (TAHRS)

The TAHRS is intended for fixation of prosthetic material to soft tissue

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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);

Design outcomes

Primary

Measure	Time frame	Description
Serious Adverse Device Effect (SADEs)	through 12 months post-surgery	Cumulative incidence of complications (CIC) related to the TAHRS including: Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,

Secondary

Measure	Time frame
Rate of hernia recurrence through 12 months post- surgery	through 12 months post-surgery

Countries

Belgium, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026