AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
Sponsor: Tissium • ClinicalTrials.gov ID: NCT07277946
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Check Eligibility →Description
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.
Interventions
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ECLIPSIUM® System
(Device)
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.
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Resorbable tacks (AbsorbaTack/SorbaFix)
(Device)
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.
Eligibility criteria
Conditions
Locations
- 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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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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