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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE
At a glance
Conditions
Where it's being run
12 sites across 10 statesStudy leadership
- Michael Rosen · PRINCIPAL_INVESTIGATOR · Northwestern University
- William Hope · PRINCIPAL_INVESTIGATOR · New Hanover Regional Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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)