LIQUIBAND FIX8® for Ventral Incisional Hernia

NCT ID: NCT07295379

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2026-04-30

Brief Summary

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).

Conditions

Hernia Incisional Ventral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

All comers

All comers treated with the study device

LIQUIBAND FIX8

Intervention Type: DEVICE

Study device

Interventions

LIQUIBAND FIX8

Study device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient is ≥ 18 years of age and ≤ 80 years of age.
• Patient had a ventral incisional hernia (this may include both primary and recurrent).
• Patient underwent a ventral incisional repair and LIQUIBAND FIX8® adhesive was used for mesh fixation (including those patients where supplemental fixation was used)
• Has a minimum of 12 months follow-up.

Exclusion Criteria

• Every patient who required a ventral incisional hernia repair without concomitant parastomal hernia repair that meets the eligibility criteria will be included in this study. There will be no exclusions specific to the device. Any exclusions relating to device labelling, will have been established as part of the patient's standard of care, prior to the surgical procedure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Medical Solutions Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Lancaster Infirmary

Lancaster, , United Kingdom

Countries

United Kingdom

Central Contacts

Charlotte Moss

Role: CONTACT

Phone: +44 (0) 7918915377

Email: charlotte.moss@admedsol.com

Facility Contacts

Paul Wilson

Role: primary

Other Identifiers

LBF8-03

Identifier Type: -

Identifier Source: org_study_id