🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-06-09)

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

🟢 Recruiting Protocol / Phase N/A ⚙️ Medical Device Protocol Sponsor: Tissium

🩺 Protocol 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.

Primary Research Facility: VA Loma Linda (Loma Linda, California)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Hernia?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 22 Years or older?

🔍 Protocol Specified Minimum Age: 22 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 12 Registered Participating Sites

📍 Primary Site Map

Site: VA Loma Linda — Loma Linda, California

📍 All Participating Trial Locations (12 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. VA Loma Linda — Loma Linda, California

2. University of Florida Health — Gainesville, Florida

3. Northwestern University - Feinberg School of Medicine — Chicago, Illinois

4. University of Kentucky — Lexington, Kentucky

5. University of Michigan Medical Center — Ann Arbor, Michigan

6. Creighton University — Omaha, Nebraska

7. Duke University — Durham, North Carolina

8. Novant Health New Hanover Regional Medical Center — Wilmington, North Carolina

9. Cleveland Clinic Foundation — Cleveland, Ohio

10. The Ohio State University Wexner Medical Center — Columbus, Ohio

11. University of Tennessee Medical Center — Knoxville, Tennessee

12. Tidewater Physicians Multi Specialty Group Hernia Center — Newport News, Virginia

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07277946 • Last Synced: 2026-06-09

View on ClinicalTrials.gov ↗