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
Phase: NA
Conditions: Hernia, Inguinal Hernia, Femoral Hernia, Groin Hernia
Sponsor: Advanced Medical Solutions Ltd.

 
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. 
 
Clinical Evaluation of LiquiBand FIX8® 
 
Protocol Number: LBF8-01 
NCT Number: NCT 04009213 
 
 
Study Investigator 
John Scott Roth, MD 
University of Kentucky College of 
Medicine 
Dept. of Surgery 
800 Rose St. 
C-222 Albert Chandler Medical Center 
Lexington KY 40536 USA 
Version / Date of Protocol 
Version 1.3 / 08Jan2021 
 
 
 
 
 
 
 
 

Overview 
Laparoscopic hernia mesh fixation has become more commonplace worldwide for abdominal 
herniorrhaphy since first demonstrated in the early 1990’s [1] [2].  Mesh fixation by this technique 
typically requires the use of a mechanical fastener, such as suture or a screw-like tack to physically 
attach the mesh to the abdominal wall.  While providing strong fixation, permanent metal fasteners 
have been associated with high instances of chronic pain and other complications.  Absorbable 
fasteners have been more recently developed as alternatives to permanent devices, however chronic 
pain continues to be an issue due to the associated penetration of abdominal tissues [2].  Surgical 
adhesives have recently been promoted as an alternative to mechanical fasteners due to their strong 
adhesive properties, without tissue penetration.  These adhesives have been used as alternatives to 
other penetrative wound closure methods such as sutures and staples in topical wound closure since 
the late 1990’s [3].  Most commonly formulated from cyanoacrylate polymers, these adhesives rapidly 
polymerize in contact with moisture on the skin to bond opposing sides of a wound forming an 
effective and durable wound closure.  The LiquiBand FIX8® device incorporates a similar cyanoacrylate 
adhesive formulation, packaged in a laparoscopic delivery instrument to provide internal mesh and 
peritoneal tissue fixation as opposed to topical wound closure.  LiquiBand FIX8® obtained CE-marking 
for approval in the European Union in 2014 for inguinal hernia mesh fixation and is now approved for 
peritoneal closure in addition to other indications. In addition to the EU, LiquiBand FIX8® is approved 
for use in multiple other countries worldwide including Australia, Canada, Israel and the United Arab 
Emirates.  Independent evaluations of the LiquiBand FIX8® device have found it to be safe and 
effective for hernia mesh fixation and peritoneal closure, and although the authors stated the low 
occurrence of complications, the limited scope of these studies did not include a detailed review of 
post-operative pain [4] [5] [6] [7] [8] [9] [11].  In this study, further evaluation of the clinical 
performance and safety of the LiquiBand FIX8® device is proposed, including the detailed assessment 
of any long term post operative pain and other complications experienced by study subjects. 
 
 
 
 
 
 
 
 
 
 
 

 
CLINICAL INVESTIGATION SUMMARY 
Study Title:  
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. 
Investigational Device: 
LiquiBand FIX8® Hernia Mesh Fixation Device 
Device Description: 
The device consists of: 
a) n-butyl-2-cyanoacrylate adhesive monomer, in liquid form, supplied in a 
thin-walled, sealed glass vial; and, 
b) a surgically invasive, laparoscopic 5mm diameter cannula, with a handle 
at the proximal end incorporating a loading chamber, filter, piston 
chamber and trigger. The distal tip of the device is open to allow the 
adhesive to be dispensed from it. 
The device is designed to be used in conjunction with a 5 mm diameter 
laparoscopic port sleeve. Both the cyanoacrylate adhesive in the glass vial 
and the surgically invasive delivery device are supplied sterile, for single use 
only.  
Indication for Use: 
The LiquiBand FIX8® device is intended for use in laparoscopic surgical repair 
of groin (femoral and inguinal) hernias, achieved through the fixation of 
prosthetic mesh to the abdominal wall and the approximation of 
peritoneum. 
Design:  
Prospective, two-arm, randomized, single blinded, multi-center study. 
Purpose:  
To demonstrate the efficacy and safety of LiquiBand FIX8® for groin hernia 
repair. 
Objectives: 
Primary: 
1. To compare the improvement in pain following groin hernia repair by 
LiquiBand FIX8® to control device as measured by Visual Analog Scale 
(VAS) at baseline (worst pain experienced within 1 month of screening 
visit) and at six months post hernia repair. 
Secondary: 
1. To evaluate the incidence of hernia recurrence in patients following 
laparoscopic (TEP and TAPP) hernia repair using LiquiBand FIX8® or 
control device at 6 months post hernia repair. 
2. To compare the use of LiquiBand FIX8® to control device for mesh fixation 
at time of surgery. 
3. To compare the use of LiquiBand FIX8® to control devices for the 
approximation of the peritoneum (TAPP repairs only) at time of surgery. 
4. To evaluate the quality of life experienced by subjects following groin 
hernia repair by LiquiBand FIX8® or control as measured by the Carolinas 
Comfort Scale (CCS) at baseline (prior to surgery), and at 1 week, 2 weeks, 
1 month, 3 months, 6 months, 9 months and 12 months following 
surgery. 

5. To compare levels of pain experienced following laparoscopic (TEP and 
TAPP) groin hernia repair by LiquiBand FIX8® or control device, as 
measured by VAS at discharge, and at  1 week, 2 weeks, 1 month, 3 
months, 6 months, 9 months and 12 months following surgery. 
6. To evaluate the safety of LiquiBand FIX8® and control device for groin 
hernia repair by comparing incidence of all adverse events in patients 
post laparoscopic groin hernia repair. 
Number of patients: 
284 (142 per treatment arm) 
Investigational centers: 
 
 
 
 
 
 
 
Study Hypothesis 
Up to 10 investigational centers will be recruited for this study, 
including the following institutions: 
1. University of Kentucky 
2. The Ohio State UniversityPrisma Health – Upstate 
3. Overlake Medical CenterCleveland Clinic 
4. Prisma Health – Upstate 
5. Overlake Medical Center 
6. Cleveland Clinic 
 
The study hypothesis is that the LiquiBand FIX8® device is non-
inferior to a tack-based control device (AbsorbaTack™) for the 
laparoscopic (TEP and TAPP) repair of groin hernia.  Non-inferiority 
will be demonstrated in a primary efficacy endpoint of 
improvement (decrease) of pain scores, measured by Visual 
Analog Scale (VAS), between baseline (worst pain experienced 
within 1 month of screening visit) and 6 months post-operatively. 
 
 
 
 
 
 
 
 
 
 
 
 
 

INCLUSION/EXCLUSION  
 
 
 
 
 
 
 
 
Inclusion Criteria 
1. Patients who meet all the following criteria at the time of enrollment may be included: 
2. Is male or female, ≥22 years of age 
3. Is willing and able to give written informed consent 
4. Has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral) 
5. Is currently scheduled and eligible for TAPP or TEP laparoscopic groin hernia repair (inguinal or 
femoral) 
6. Hernia mesh to be used at the time of surgery is at least 4” x 6” in size and is one of the following; 
a. 3D Max™ Mesh (Bard Inc.) 
b. 3D Max™ Light (Bard Inc.) 
c. 
Parietex™ 2D (order code starting with TEC) Flat Sheet Mesh (Medtronic) 
d. Parietex™ 3D (order code starting with TET) Flat Sheet Mesh (Medtronic) 
7. Is willing and able to comply with the protocol assessments at time of surgery and during the post 
surgical follow up period 
Exclusion Criteria 
1. Patients who meet any one of these criteria will be excluded from the investigation: 
2. Has a hernia type not suitable for laparoscopic hernia repair as determined by the Investigator 
(i.e. strangulated) 
3. 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 
4. Is pregnant or actively breastfeeding 
5. Has a known sensitivity to cyanoacrylate or formaldehyde,D&C Violet No.2 dye or any 
component of LiquiBand FIX8® or control device 
6. Has an active or potential infection at the surgical site or systemic sepsis 
7. 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 #5.  
8. Cannot tolerate general anaesthesia 
9. 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. 
10. Is currently enrolled in another clinical study or undergoing treatment with another 
investigational drug or device. 

ENDPOINTS 
 
Table 1: Primary and Secondary Efficacy and Safety Endpoints of the Investigational Study 
Primary  Efficacy 1 
Effectiveness of LiquiBand FIX8® will be assessed and compared to treatment with 
AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair. 
Success will be determined by improvement in pain not inferior to control device 
as measured by a VAS value (0 = no pain to 10 = most pain imaginable) from 
baseline (worst pain experienced within 1 month of screening visit) to six months 
post hernia repair. 
Secondary Efficacy 1 
The incidence of hernia recurrence in patients following laparoscopic (TEP and 
TAPP) groin hernia repair by LiquiBand FIX8® or control (AbsorbaTack™) will be 
assessed by physical examination at 2 weeks, 3 months, and 6 months and 
evaluated following the 6 month timepoint.  Suspected hernia recurrence will also 
be evaluated at any time following surgery and up to the 12 month follow up visit 
if reported by the subject.  Suspected hernia recurrence will be confirmed by 
ultrasound imaging following physical examination.   
Secondary Efficacy 2 
LiquiBand FIX8® will be required to successfully fix hernia mesh in patients 
undergoing TEP and TAPP laparoscopic groin hernia repair, at a rate non-inferior 
to control device (AbsorbaTack™) in order to meet this end point. Successful 
mesh fixation would not require any additional fixation by alternate fixation 
device. Unsuccessful mesh fixation is defined as requiring the use of an 
alternative fixation device or additional procedure to achieve adequate fixation. 
Secondary Efficacy 3 
LiquiBand FIX8® will be required to successfully approximate the peritoneum in 
patients undergoing laparoscopic TAPP hernia repair, at a rate non-inferior to 
control devices in order to meet this end point.  Successful peritoneal closure 
would not require any additional fixation by alternate fixation device or additional 
procedure. Unsuccessful peritoneal closure is defined as requiring the use of an 
alternative fixation device or additional procedure to achieve adequate fixation. 
Investigators in the study will be able to use AbsorbaTack™, sutures or staples for 
closure of the peritoneum. 
Secondary Efficacy 4 
Quality of Life will be assessed by completion of the Carolinas Comfort Scale (CCS) 
Questionnaire prior to surgery and at 1 week, 2 weeks, 1 month, 3 months, 6 
months, 9 months and 12 months following laparoscopic (TEP and TAPP) groin 
hernia repair.  CCS scores at each timepoint will be compared between the 
LiquiBand FIX8® and control (AbsorbaTack) treatment groups. 
Secondary Efficacy 5 
Evaluation of pain will be measured  by VAS (0 = no pain to 10 = most pain 
imaginable) at baseline (pre-surgery), at discharge, and at 1 week, 2 weeks, 1 
month, 3 months, 6 months, 9 months and 12 months post surgery. 
Secondary Safety 1 
The incidence of all adverse events whether or not determined to be related to 
the LiquiBand FIX8® device or control device (AbsorbaTack™) will be assessed 
intraoperatively, at discharge, and at each follow-up visit throughout the study, 
or for cause at any time in the follow up period. 
 
 

SCHEDULE OF STUDY ASSESSMENTS 
Study design and schedule of assessments. (Shaded columns represent assessments performed in-clinic, non-
shaded for remote visits). 
 
 
Pre-
Surgery 
Surger
y 
Discharg
e 
Post-Surgery Visits 
Unscheduled 
visit 
Visit 
1 
2 
33 
4 
5 
6 
7 
8 
9 
10 
N/A 
Day / Month 
≤21 
Days  
Day 0 
Day 0 or 
1 
 
Day 
7 
Day 
14 
Month 
1 
Month 
3 
Mont
h 6 
Mont
h 9 
Month 
12 
N/A 
Visit Window 
(Days) 
 
 
 
±3 
-3 / 
+6 
±7 
±14 
-21 / 
+14 
-21 / 
+14 
-21 / 
+14 
N/A 
Informed 
Consent 
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/ 
Exclusion 
X 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test  
(if applicable) 
 
X1 
 
 
 
 
 
 
 
 
 
Medical History  
X 
 
 
 
 
 
 
 
 
 
 
Analgesics 
usage 
X 
X1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
Vital Signs 
(HR/BP/T/Ht/Wt)
4 
X 
X1 
X 
 
X 
 
X 
X 
 
 
X 
Randomization5 
 
X2 
 
 
 
 
 
 
 
 
 
Hernia 
Information (type 
& size) 
X 
X2 
 
 
 
 
 
 
 
 
 
Use of 
Investigational 
or control device 
 
X2 
 
 
 
 
 
 
 
 
 
Number of 
Investigational 
or control device 
applications 
 
X2 
 
 
 
 
 
 
 
 
 
Photograph 
following mesh 
fixation 
 
X 
 
 
 
 
 
 
 
 
 
Photograph 
following 
peritoneal 
closure6 
 
X 
 
 
 
 
 
 
 
 
 
Clinician 
evaluation of 
hernia repair & 
PE7 
 
 
 
 
X 
 
X 
X 
 
 
X 
Subject Pain  
(0-10 VAS) 
Assessment 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Subject QOL 
Assessment 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
 
AE Evaluation 
 
X2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
1Immediately prior to surgery 
2During surgery 
3At discharge post-surgery, either on same day as surgery or next day post-surgery according to standard of care 
4Height only required at Pre-surgery visit.  Unless Pre-surgery (Visit 1), Surgery (Visit 2) and Discharge (Visit 3) occur on the 
same date, weight should be obtained for each separate visit.  Vital signs may be obtained remotely at Month 3 and 6 visits 
as volunteered by subjects using their own devices as available (e.g. thermometer, weight scales, smart wearable 
technology) 
5Patient must be blinded to the randomized device 
6Photograph following peritoneal closure only required for TAPP repairs 
7Suspected hernia recurrence will be confirmed by ultrasound imaging following physical examination 
 

STATISTICAL CONSIDERATIONS 
Statistical Hypotheses 
Statistical methods are presented below. 
Primary Endpoint: Effectiveness of LiquiBand FIX8® will be assessed and compared to treatment with 
AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair. Success will be 
determined by improvement in pain not inferior to control device as measured by a VAS value (0 = no 
pain to 10 = most pain imaginable) from baseline (worst pain experienced within 1 month of screening 
visit) to six months post hernia repair. 
The statistical hypothesis is: 
H0: δT - δC ≥ 0.9[21, 22] 
H1: δT - δC < 0.9 [21, 22],  
where δ is the change from baseline (worst pain experienced within 1 month of screening visit) to 
6-month on VAS for the appropriate treatment group.   
 
Secondary Endpoints: To assess efficacy and safety outcomes following TAPP or TEP laparoscopic 
groin hernia (femoral and inguinal) repair by LiquiBand FIX8® compared to AbsorbaTack™ by 
evaluating the following: 
• 
Recurrence rate in subjects following laparoscopic (TEP and TAPP) groin hernia repair by 
LiquiBand FIX8® or control (AbsorbaTack™) at 2 weeks, 3 months, 6 months, and 12 months.  
The statistical hypothesis for the recurrence rate at 6 months is:  
H0: qT – qC ≥ 10%[25] 
H1: qT – qC < 10%[25],  
where q is the recurrence rate at 6 months for the appropriate treatment group. 
• 
Rate of successful hernia mesh fixation in subjects undergoing TEP and TAPP laparoscopic groin 
hernia repair.   
The statistical hypothesis is:  
H0: pC - pT ≥ 10% 
H1: pC - pT < 10%,  
where p is the rate of successful hernia mesh fixation at time of surgery for the 
appropriate treatment group. 
• 
Rate of successful peritoneal closure in subjects undergoing laparoscopic TAPP hernia repair.   
The statistical hypothesis is:  
H0: πC - πT ≥ 15% 
H1: πC - πT < 15%,  
where π is the rate of peritoneal closure at time of surgery for the appropriate 
treatment group. 
• 
Quality of Life assessed by the Carolinas Comfort Scale (CCS) Questionnaire prior to surgery and 
at 7 days, 14 days, 1 month, 3 months, 6 months, 9 months and 12 months following 
laparoscopic (TEP and TAPP) groin hernia repair.   
 
Population for Analysis 
The following subject populations will be created: 
 

• 
Intent-to-Treat (ITT): All enrolled subjects. ITT analysis will be per randomized group irrespective 
of the treatment actually received. 
• 
Per Protocol (PP): All ITT subjects excluding those with major protocol violations. PP analysis will 
be per actual treatment group which is the same as the treatment initially randomized. 
• 
As the PP analysis is more conservative for non-inferiority hypothesis, all hypotheses will be tested 
with the PP population. ITT analysis will also be performed for all hypotheses, as the primary 
analysis for the primary endpoint, and the supportive analysis for secondary endpoints with non-
inferiority hypothesis. 
 
Statistical Analysis 
General Approach 
The primary efficacy endpoint will be tested for non-inferiority of treatment to control with a 
predefined non-inferiority margin of 0.9 on the VAS scale. Confounding factors for the pain score 
including analgesic use or other pain management therapies will be measured at screening and all 
follow up visits, and compared between treatment arms to ensure proper balance within each site. 
The study will be claimed successful if both PP and ITT analyses on the primary efficacy endpoint 
showed significance at 0.025. Once the hypothesis tests succeed for both analysis sets on the primary 
efficacy endpoint, key secondary endpoints will be compared between treatments sequentially in a 
non-inferiority manner. The following sequential analysis approach will be taken: 
• 
Primary non-inferiority on the PP set; if significant at one-sided alpha=0.025, and 
• 
Primary non-inferiority on the ITT set; if significant at one-sided alpha=0.025, then proceed to key 
secondary endpoints detailed in Section 3.1. 
• 
Secondary non-inferiority on the PP set on Hernia Recurrence rate in subjects following 
laparoscopic (TEP and TAPP) groin hernia repair by LiquiBand FIX8® or control (AbsorbaTack™) at 
6 months, at one-sided alpha=0.025. 
• 
Secondary non-inferiority on the PP set on Rate of successful hernia mesh fixation in subjects 
undergoing TEP and TAPP laparoscopic groin hernia repair; if significant at one-sided alpha=0.025, 
then 
• 
Secondary non-inferiority on the PP set on Rate of successful peritoneal closure in subjects 
undergoing laparoscopic TAPP hernia repair; if significant at one-sided alpha=0.025, then 
The family-wise type I error will therefore be controlled at 0.025. 
 
Summary statistics will consist of the number and percentage of responses in each category for 
discrete variables, and the mean, median, standard deviation (SD), minimum, and maximum for 
continuous variables. One-sided statistical tests will use a significance level of α = 0.025, and two-
sided tests will use a significance level of α = 0.05.   
 
Analysis of the Primary Efficacy Endpoint 
To test change from baseline (worst pain experienced within 1 month of screening visit) to 6-month 
on VAS between LiquiBand FIX8® and AbsorbaTack™, a general linear model (ANCOVA) will be run 
using SAS Proc GLM, with the treatment arm and laparoscopic repair technique (TAPP or TEP) as 
covariates. (SAS Institute Inc. NC USA). A p-value of < 0.025 will be considered evidence that LiquiBand 
FIX8® is not inferior to the AbsorbaTack™. 95% confidence interval will be calculated for the difference 
on changes from baseline (screening visit) to 6-month visit on VAS between LiquiBand FIX8® and 
AbsorbaTack™.  This endpoint will be assessed when the enrollment is completed, i.e., when 148 
subjects have been enrolled in the TAPP cohort, and there are at least 226 evaluable subjects with 6-

month data for change from baseline to 6-month on VAS. Tipping point analysis will also be performed 
to evaluate the impact of missing data. 
 
Analysis of the Secondary Endpoints 
The following safety and clinical outcomes will be evaluated.  
The safety and clinical outcomes assessments include: 
1. Hernia recurrence up to 12 months following surgery. 
2. Hernia mesh fixation at time of surgery. 
3. Approximation of the peritoneum at time of surgery (TAPP repairs only). 
4. Quality of Life following groin hernia repair as measured by Carolinas Comfort Scale at baseline 
and at 7 days, 14 days, 1 month, 3 months, 6 months, 9 months and 12 months following 
laparoscopic (TEP and TAPP) groin hernia repair. 
5. Subject pain following groin hernia repair as reported by VAS at screening, discharge and at 7 
days, 14 days, 1 month, 3 months, 6 months, 9 months and 12 months following surgery. 
6. Rate of device and procedure-related adverse events reported throughout the duration of the 
study. 
To test the secondary endpoints #1, 2, and 3, a binomial non-inferiority test will be run using SAS Proc 
Freq with the Farrington-Manning method on the PP set. A p-value of < 0.025 from the binomial non-
inferiority test will be considered evidence that LiquiBand FIX8® is not inferior to AbsorbaTack™. 
Confidence interval on the difference of the rates will be reported and non-inferiority is indicated if 
the upper limit of the confidence interval is less than the non-inferiority margin. ITT analyses will be 
performed for the three secondary endpoints with hypothesis statements as supporting sensitivity 
analyses. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Bibliographical References 
 
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