TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042205
• Other study ID #: PF00006-CLPR-002
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2023
• Est. completion date: March 28, 2025

Study information

• Verified date: March 2024
• Source: Tissium
• Contact: Sr. Manager, Clinical Affairs
• Phone: +1 857-408-0709
• Email: ntrinward[@]tissium.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 28, 2025
• Est. primary completion date: March 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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);

Related Conditions & MeSH terms

• Hernia

Intervention

Device:
• TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
The TAHRS is intended for fixation of prosthetic material to soft tissue

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	Ziekenhuis Oost-Limburg [ZOL]	Genk	Limburg
Belgium	AZ Sint-Jan	Ruddershove
Belgium	CHU UCL Namur	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
Tissium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Device Effect (SADEs)	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,	through 12 months post-surgery
Secondary	Rate of hernia recurrence through 12 months post- surgery		through 12 months post-surgery