PMCF Study of LiquiBand FIX8® OHMF Device
Research type
Research Study
Full title
PMCF study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device
IRAS ID
261975
Contact name
Andre Mihailescu
Contact email
Sponsor organisation
Advanced Medical Solutions
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study is designed to evaluate the performance of a device called the LiquiBand FIX8 Open device in inguinal hernia repair surgery. The use of the FIX8 Open device is not experimental, as it is already been approved for use in the EU (CE-marked). The purpose of this study is to collect information about the use of the FIX8 Open device in a real-world setting. This type of study is known as a “post-market clinical follow-up” or PMCF study. An inguinal hernia is a bulging of tissue through a weakness in the abdominal wall. Symptoms include pain over abdomen and abdominal wall, aching and pressure worsened when bending, lifting or coughing. Standard of care for an inguinal hernia is fixation of a mesh over the hernia and the LiquiBand FIX8 Open device is an atraumatic device specifically engineered for strong mesh fixation of hernia repair meshes. Hernia repair meshes are woven sheets of flexible synthetic plastic which are placed tension-free over the weakness in the abdominal wall, essentially ‘plugging’ it up. Tension is created in the abdominal wall during repair, but the mesh allows this tension to be spread out. The mesh must be secured to the underlying tissue and this is often done with the use of tacks or sutures, however, the study device instead uses a glue (N-Butyl 2 cyanoacrylate adhesive) to secure the mesh. The FIX8 Open device is designed for the application of this glue to the implanted hernia repair mesh in order to fix the mesh to the underlying tissue. When the glue is applied to the mesh and tissue, it polymerises (forms a chemical bond) due to the moisture on the tissue surface within approximately 10 seconds and allows the mesh to remain in the correct position. The study device can also be used to close topical wounds (the opening that the surgeon makes on the surface of the abdomen to access the hernia).
REC name
North of Scotland Research Ethics Committee 2
REC reference
20/NS/0060
Date of REC Opinion
18 May 2020
REC opinion
Favourable Opinion