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.
Patient is 22 years old or older.
Patient is willing and able to provide a signed Patient Informed Consent Form.
Patient has a single midline primary ventral, umbilical, or incisional hernia;
Patient is scheduled for a laparoscopic IPOM hernia repair.
Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, comparator device, mesh, or other surgical products (e.g., sutures).
Patient is taking systemic photosensitivity pharmaceutical products at time of informed consent.
Patient has a BMI > 40.
Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day.
Parallel
ECLIPSIUM® System
DeviceThe 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 (AbsorbaTack/SorbaFix)
DeviceResorbable 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.
Hernia Recurrence at 6 months
Rate of hernia recurrence of the ECLIPSIUM System compared to resorbable tacks at 6 months post-surgery.
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)
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.
