A multi-center, randomized, controlled, single blinded, parallel-group study evaluating the clinical performance and safety of LiquiBand FIX8 versus control for hernia mesh fixation and peritoneal closure in groin hernia repair.
This is a study involving participants who are scheduled to undergo a surgical procedure called groin hernia repair with mesh fixation. It will be comparing post-operative pain and quality of life following surgery between two mesh fixation devices, the AbsorbaTack device currently approved in the United States verses the investigational FIX8 device. A hernia is a protrusion of tissue through a weakness in the abdominal wall. Groin hernias are the most common type of hernia and pain following surgery can be disruptive to a person’s quality of life while healing occurs. During surgery to repair a hernia, a woven plastic cover called a mesh is used to plug up the defect in the abdominal wall to prevent reoccurrence of the hernia. The AbsorbaTack device that is currently used to fixate mesh to the abdominal wall uses screw-like tacks directly inserted into the surrounding tissue. The product being investigated in this trial uses a less invasive adhesive that does not require tissue penetration. This less invasive method may result in less pain following surgery and a shorter duration of pain. It may also decrease the risk of fixation failure and subsequent need for a repeated surgery.
Overlake Medical Center
1035 116th Ave NE
Bellevue, WA 98004
Phone: (425) 688-5000
- ClinicalTrials.gov: Use NCT04009213 as the identifier to view a full description of this study.