ECLIPSIUM System for Hernia Repair

This study is looking at a new way to fix hernias (a bulge caused by an organ pushing through a weak spot in muscle or tissue) using the ECLIPSIUM® System. This system uses a special coating that is applied to the mesh (a surgical material used to repair the hernia) and then hardened with light to hold it in place. Researchers want to see if ECLIPSIUM is as safe and effective as traditional resorbable tacks (small fasteners that dissolve over time) in preventing the hernia from coming back. You could be eligible if you are at least 22 years old and have a specific type of hernia that is 1-5 cm in size. The study will measure if the hernia returns after 6 months and track any complications for 12 months. The current recruitment status is unclear.

Study design
This study is a randomized, active control, single-blind study involving 240 participants. This means participants will be randomly assigned to receive either the ECLIPSIUM System or resorbable tacks, and you won't know which treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 12 months after your surgery to check for complications, and for 6 months to see if the hernia returns.

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NCT07277946

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

Recruiting
NAAges 22+InterventionalTreatment
Tissium
~240 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:ECLIPSIUM® SystemResorbable tacks (AbsorbaTack/SorbaFix)

At a glance

Recruiting sites
5 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hernia Recurrence at 6 months
Measured over 6 months
+1 more outcome measured
Hernia
12 sites across 10 states
North Carolina2
Ohio2
California1
Florida1
Illinois1
Kentucky1
Michigan1
Nebraska1
  • Michael Rosen · PRINCIPAL_INVESTIGATOR · Northwestern University
  • William Hope · PRINCIPAL_INVESTIGATOR · New Hanover Regional Medical Center

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  • Hernia Recurrence at 6 months6 months

    Rate of hernia recurrence of the ECLIPSIUM System compared to resorbable tacks at 6 months post-surgery.

  • Cumulative Incidence of Complications12 months

    Safety of the ECLIPSIUM System will be assessed by collecting and analyzing the cumulative incidence of complications (CIC) related to the ECLIPSIUM System including the following complications: * Infection * Chronic pain (defined as moderate or greater pain lasting more than 3 months) not otherwise specified * Impaired/delayed healing at the surgical site (i.e. hernia repair site; example dehiscence) * Allergic reaction/hypersensitivity reaction to the constituent polymer of the investigational device * Serious Adverse Device Effect (SADEs)