LIQUIBAND FIX8® for Ventral Incisional Hernia

NCT07295379 | Not Yet Recruiting

• 1 other identifier: LBF8-03
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Performance of LIQUIBAND FIX8

  The performance of LIQUIBAND FIX8® adhesive when used as a method of mesh fixation (independently or in conjunction with another mesh fixation device) during ventral incisional hernia, through reported hernia recurrence rates at 12 months post-surgery.

  From surgery to end of follow-up at 12 months

Secondary Outcomes (4)

• Reoperation incidence

  From surgery to end of follow-up at 12-months

• SSI incidence

  From surgery to end of follow-up at 12-months

• Chronic pain incidence

  From surgery to end of follow-up at 12-months

• Adverse Events

  From surgery to end of follow-up at 12-months

Study Arms (1)

All comers

All comers treated with the study device

Device: LIQUIBAND FIX8

Interventions

LIQUIBAND FIX8 DEVICE

Study device

All comers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All comers for ventral incisional hernia repair at Royal Lancaster Infirmary performed by study Investigator

You may qualify if:

• 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.

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead

Study Sites (1)

Royal Lancaster Infirmary

Lancaster, LA1 4RP, United Kingdom

Location

Central Study Contacts

Charlotte Moss

CONTACT

+44 (0) 7918915377; charlotte.moss@admedsol.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 20, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)