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.
A prospective, multi-center, randomized, active control, single-blind non- inferiority study designed to evaluate the safety and effectiveness of the ECLIPSIUM® System versus bioresorbable tacks in mesh fixation in patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
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.
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.
VA Loma Linda
Loma Linda, California, United States
NOT_YET_RECRUITINGUniversity of Florida Health
Gainesville, Florida, United States
NOT_YET_RECRUITINGNorthwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
RECRUITINGUniversity of Kentucky
Lexington, Kentucky, United States
NOT_YET_RECRUITINGUniversity of Michigan Medical Center
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGCreighton University
Omaha, Nebraska, United States
NOT_YET_RECRUITINGDuke University
Durham, North Carolina, United States
NOT_YET_RECRUITINGNovant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
RECRUITINGCleveland Clinic Foundation
Cleveland, Ohio, United States
NOT_YET_RECRUITINGThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITING...and 2 more locations
Hernia Recurrence at 6 months
Rate of hernia recurrence of the ECLIPSIUM System compared to resorbable tacks at 6 months post-surgery.
Time frame: 6 months
Cumulative Incidence of Complications
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)
Time frame: 12 months
Hernia Recurrence at 12 months
The secondary efficacy outcome of this study is to demonstrate the rate of hernia recurrence of the ECLIPSIUM System is non-inferior compared to resorbable tacks at 12 months post-surgery.
Time frame: 12 months
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