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LIQUIBAND FIX8® for Ventral Incisional Hernia

Study acronym: LBF8-03
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record status
This record was last updated July 8, 2026 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Trial status: Not Yet Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Primary and study completion dates: Apr 30, 2026 to Jul 30, 2026
    • Start date changed from estimate of Dec 20, 2025 to Feb 2, 2026
    • Eligibility criteria shortened, about 46 words
    • Site contact updated
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07295379
Lead Sponsor Advanced Medical Solutions Ltd.
Conditions
(from sponsor)
Hernia Incisional Ventral
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov