NCT04009213

A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Advanced Medical Solutions Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hernia
• Inguinal Hernia
• Femoral Hernia
• Groin Hernia

Interventions

Type	Name	Description
DEVICE	LiquiBand FIX8®	An n-butyl-2-cyanoacrylate adhesive monomer and D\&C Violet #2 dye
DEVICE	AbsorbaTack™	An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D\&C Violet No. 2.

Timeline

• Start date: 2019-08-22
• Primary completion: 2022-06-13
• Completion: 2022-11-23
• First posted: 2019-07-05
• Last updated: 2024-01-11
• Results posted: 2024-01-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study