RecruitingNot ApplicableNCT07277946

AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE


Sponsor

Tissium

Enrollment

240 participants

Start Date

May 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this clinical trial is to assess the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. The study will evaluate whether ECLIPSIUM, a bioresorbable polymer-based fixation device, is effective in reducing the risk of hernia recurrence when compared with bioresorbable tacks. This information will support understanding of ECLIPSIUM's potential clinical benefits in ventral hernia repair.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ECLIPSIUM® System and a medical device called Resorbable tacks (AbsorbaTack/SorbaFix) for people with hernia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEECLIPSIUM® System

The ECLIPSIUM® System functions by applying a biodegradable, implantable polymer coating to the prosthetic material under guidance of a template to ensure appropriate application, followed by in situ photo-activation using the TISSIUM curing light to secure the mesh to the abdominal wall.

DEVICEResorbable tacks (AbsorbaTack/SorbaFix)

Resorbable tacks are surgical fasteners used to secure a hernia mesh in place. Resorbable tacks are designed to be absorbed by the body over time, gradually losing strength as the tissue ingrowth into the mesh occurs and takes over the support function.


Locations(12)

VA Loma Linda

Loma Linda, California, United States

University of Florida Health

Gainesville, Florida, United States

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, United States

University of Kentucky

Lexington, Kentucky, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Creighton University

Omaha, Nebraska, United States

Duke University

Durham, North Carolina, United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Tidewater Physicians Multi Specialty Group Hernia Center

Newport News, Virginia, United States

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NCT07277946


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