ECLIPSIUM System for Hernia Repair

(UNITE Trial)

This trial tests a new device called ECLIPSIUM for securing meshes during hernia repair surgery. The researchers aim to determine if ECLIPSIUM can safely and effectively reduce hernia recurrence compared to other methods, such as resorbable tacks. The trial specifically targets individuals with a single ventral hernia (a bulge through the abdominal wall) between 1 to 5 cm in size who are scheduled for minimally invasive repair. Participants should not have previous hernia repairs with mesh or a history of smoking. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance hernia repair techniques.

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking systemic photosensitivity drugs, systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent.

Earlier studies have shown that the ECLIPSIUM System enhances precision in laparoscopic (minimally invasive) hernia repair and reduces tissue damage. This system uses a special material that the body can safely absorb over time. Reports from early trials indicated that patients tolerated the device well, with no major side effects directly linked to the ECLIPSIUM System. The device's absorption aims to lower the risk of complications associated with other surgical fasteners.

The ECLIPSIUM System is unique because it uses a biodegradable implantable polymer to attach hernia mesh to internal soft tissue without penetrating it. Unlike current options, like resorbable tacks, which act as fasteners that are gradually absorbed by the body, the ECLIPSIUM System involves a non-penetrating method that may reduce tissue damage and improve healing. Researchers are excited about this treatment because it represents a less invasive approach, potentially leading to quicker recovery times and fewer complications for patients undergoing hernia repair.

Research has shown that the ECLIPSIUM System, which participants in this trial may receive, might reduce the chances of hernia recurrence by improving how the repair mesh attaches during surgery. This new device uses a special material that safely dissolves in the body over time. Early results suggest that ECLIPSIUM may cause less damage compared to traditional methods. In this trial, resorbable tacks, which are fasteners that disappear after supporting the mesh, serve as the active comparator. Studies have found that using mesh in hernia repair usually leads to fewer recurrences and complications. By enhancing procedural precision, ECLIPSIUM aims to achieve similar or better results in preventing hernias from returning and aiding recovery.¹²⁶⁷⁸