NCT07295379: LBF8-03

LIQUIBAND FIX8® for Ventral Incisional Hernia

Not yet recruiting Last updated 19 December 2025

What this trial tests

trial testing LIQUIBAND FIX8 in Hernia Incisional Ventral in 148 participants. Not yet recruiting.

Timeline

20 December 2025

Primary endpoint
30 April 2026

30 April 2026

Quick facts

Lead sponsor	Advanced Medical Solutions Ltd.
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	148
Start date	20 December 2025
Primary completion	30 April 2026
Estimated completion	30 April 2026
Sites	1 location across United Kingdom

Drugs / interventions tested

• LIQUIBAND FIX8

Conditions studied

• Hernia Incisional Ventral — all drugs for Hernia Incisional Ventral →

Sponsor

Advanced Medical Solutions Ltd.

Who can join

Adults 18 to 80, any sex, with Hernia Incisional Ventral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to evaluate the safety and performance of device LiquiBand FIX8 Open hernia mesh fixation device. The use of this device is not experimental, as it is already approved for use in the EU (CE-marked). This is a retrospective post market clinical follow-up study to collect information about the use of the device in a real-world setting for ventral incisional hernia repair. Ventral incisional hernias occur following surgery and the most common method of treatment includes implanting a mesh, which in the case of ventral incisional hernia, the standard of care is intra-peritoneal onlay mesh. This is fixed in place using sutures, tacks or adhesive.

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 peritoneum 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 to access the hernia).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.