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TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study

Primary Purpose

Hernia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
TISSIUM™ Adhesive Hernia Repair System (TAHRS)
Sponsored by
Tissium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Subject is 18 years old or older; Patient willing and able to provide a signed Patient Informed Consent Form; Has a midline primary ventral, umbilical or incisional hernia; Scheduled for a laparoscopic IPOM hernia repair; Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect Key Exclusion Criteria: Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures); BMI > 35; Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day; Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent; Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding; Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus; Patient has more than one hernia defect (to be confirmed intraoperatively);

Sites / Locations

  • Imelda HospitalRecruiting
  • AZ Sint-JanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hernia repair

Arm Description

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)

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

Rate of hernia recurrence through 12 months post- surgery

Full Information

First Posted
September 8, 2023
Last Updated
September 14, 2023
Sponsor
Tissium
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1. Study Identification

Unique Protocol Identification Number
NCT06042205
Brief Title
TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2023 (Actual)
Primary Completion Date
December 27, 2024 (Anticipated)
Study Completion Date
December 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tissium

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hernia repair
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
TISSIUM™ Adhesive Hernia Repair System (TAHRS)
Intervention Description
The TAHRS is intended for fixation of prosthetic material to soft tissue
Primary Outcome Measure Information:
Title
Serious Adverse Device Effect (SADEs)
Description
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,
Time Frame
through 12 months post-surgery
Secondary Outcome Measure Information:
Title
Rate of hernia recurrence through 12 months post- surgery
Time Frame
through 12 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Subject is 18 years old or older; Patient willing and able to provide a signed Patient Informed Consent Form; Has a midline primary ventral, umbilical or incisional hernia; Scheduled for a laparoscopic IPOM hernia repair; Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect Key Exclusion Criteria: Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures); BMI > 35; Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day; Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent; Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding; Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus; Patient has more than one hernia defect (to be confirmed intraoperatively);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sr. Manager, Clinical Affairs
Phone
+1 603-630-2241
Email
ntrinward@tissium.com
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tollens
Facility Name
AZ Sint-Jan
City
Ruddershove
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cauwenberge
First Name & Middle Initial & Last Name & Degree
Van Cauwenberge

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study

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