At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Controlled, Single Blinded, Parallel-group Study Evaluating the Clinical Performance and Safety of LiquiBand FIX8® Versus Control for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
In Brief
A clinical study evaluating LiquiBand FIX8® and AbsorbaTack™ for Hernia and 3 related conditions. Completed, enrolled 284 participants across 6 sites.
Detailed Summary
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used. The objective of this study is to compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control device (AbsorbaTack™) for laparoscopic groin hernia (inguinal or femoral) repair. The primary outcome measure is an improvement in pain score measured by VAS at 6 months. Secondary outcomes include the ability to affix hernia mesh, the ability to approximate the peritoneum, recurrence rate, and quality of life (Carolina Comfort Scale).
Study Details
Timeline
Interventions
An n-butyl-2-cyanoacrylate adhesive monomer and D\&C Violet #2 dye
An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D\&C Violet No. 2.