N/A N=284 Randomized Single-blind Treatment

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

Hernia · Inguinal Hernia · Femoral Hernia · Groin Hernia

Bottom Line

View on ClinicalTrials.gov: NCT04009213 ↗

Enrolled (actual)

284

Serious AEs

9.5%

Results posted

Jan 2024

Primary outcome: Primary: Change in Pain — -4.9; -5.1 score on a VAS scale — p=< 0.025

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LiquiBand FIX8® (Device); AbsorbaTack™ (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Advanced Medical Solutions Ltd.
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain	-4.9; -5.1	< 0.025 sig
SECONDARY Number of Participants With Hernia Recurrence	1; 2	< 0.025 sig
SECONDARY Successful Mesh Fixation at the Time of Surgery.	142; 142	<0.025 sig
SECONDARY Incidence of Successful Peritoneal Closure (TAPP Repairs Only)	82; 84	< 0.025 sig
SECONDARY Quality of Life as Measured by the Carolinas Comfort Scale (CCS).	-7.7; -7.0; -12.4; -12.2; -14.6; -14.4	—
SECONDARY Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).	-0.3; -0.1; -1.5; -1.5; -2.8; -2.7	—
SECONDARY Safety as Measured by the Incidence of Adverse Events.	114; 157	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04009213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.