TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study

• Sponsor: Tissium (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06042205
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 17.8
• Patients Per Site: 6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hernia	Device: TISSIUM™ Adhesive Hernia Repair System (TAHRS)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Adhesive Hernia Repair System (TAHRS) for Atraumatic Laparoscopic Hernia Repair
• Actual Study Start Date: Jul 4, 2023
• Anticipated Primary Completion Date: Dec 27, 2024
• Anticipated Study Completion Date: Dec 27, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hernia repair There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Adhesive Hernia Repair System (TAHRS)	Device: TISSIUM™ Adhesive Hernia Repair System (TAHRS); The TAHRS is intended for fixation of prosthetic material to soft tissue

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Rate of hernia recurrence through 12 months post- surgery [through 12 months post-surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 > 35;

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);

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imelda Hospital	Bonheiden		Belgium
2	AZ Sint-Jan	Ruddershove		Belgium

Sponsors and Collaborators

• Tissium

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tissium
• ClinicalTrials.gov Identifier: NCT06042205
• Other Study ID Numbers: PF00006-CLPR-002
• First Posted: Sep 18, 2023
• Last Update Posted: Sep 18, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hernia

Study Results

No Results Posted as of Sep 18, 2023