Completed

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

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What is being tested

LiquiBand FIX8®

+ AbsorbaTack™

Device
Who is being recruted

Hernia+3

+ Hernia, Femoral

+ Hernia, Inguinal

Over 22 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2019
See protocol details

Summary

Principal SponsorAdvanced Medical Solutions Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 22, 2019

Actual date on which the first participant was enrolled.

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).

Official TitleA 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
NCT04009213
Principal SponsorAdvanced Medical Solutions Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

284 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 22 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HerniaHernia, FemoralHernia, InguinalPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHernia, Abdominal

Criteria

Inclusion Criteria: Is male or female, ≥22 years of age Is willing and able to give written informed consent Has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral) Is currently scheduled and eligible for TAPP or TEP laparoscopic groin hernia repair (inguinal or femoral) Hernia mesh to be used at the time of surgery is at least 4" x 6" in size and is one of the following; * 3D Max™ Mesh (Bard Inc.) * 3D Max™ Light (Bard Inc.) * Parietex™ 2D (order code starting with TEC) Flat Sheet Mesh (Medtronic) * Parietex™ 3D (order code starting with TET) Flat Sheet Mesh (Medtronic) Is willing and able to comply with the protocol assessments at time of surgery and during the post surgical follow up period Exclusion Criteria: Has a hernia type not suitable for laparoscopic hernia repair as determined by the Investigator (i.e. strangulated) Subject has a recurrent groin hernia previously repaired laparoscopically, has an anatomical defect or had prior surgical procedures that in the opinion of the Investigator prevents access to the pre-peritoneal space for TAPP or TEP laparoscopic hernia repair Is pregnant or actively breastfeeding Has a known sensitivity to cyanoacrylate or formaldehyde,D\&C Violet No.2 dye or any component of LiquiBand FIX8® or control device Has an active or potential infection at the surgical site or systemic sepsis Hernia mesh to be used at surgery is less than 4"x6" in size, or not one of the types of mesh listed in Inclusion Criteria above Cannot tolerate general anaesthesia Has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D\&C Violet #2 dye

Group II

Active Comparator
AbsorbaTack™ is an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D\&C Violet No. 2

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Cleveland Clinic

Weston, United StatesOpen Cleveland Clinic in Google Maps
Suspended

University of Kentucky College of Medicine UK Medical Center

Lexington, United States
Suspended

Cleveland Clinic Foundation

Cleveland, United States
Suspended

The Ohio State University Wexner Medical Center

Columbus, United States
Completed6 Study Centers