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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

Primary Purpose

Hernia, Inguinal Hernia, Femoral Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LiquiBand FIX8®
AbsorbaTack™
Sponsored by
Advanced Medical Solutions Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring Laparoacopic, Peritoneal Closure

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic
  • University of Kentucky College of Medicine UK Medical Center
  • Cleveland Clinic Foundation
  • The Ohio State University Wexner Medical Center
  • Greenville Memorial Hospital
  • Overlake Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LiquiBand FIX8®

AbsorbaTack™

Arm Description

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

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

Outcomes

Primary Outcome Measures

To compare the change 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.
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. The Visual Analog Scale (VAS) consists of a straight line with the endpoints defining extreme limits, 0 = no pain and 10 = worst pain imaginable. The patient is asked to mark his/her pain level on the line between the two endpoints.

Secondary Outcome Measures

To evaluate the incidence of hernia recurrence in patients following laparoscopic (TEP and TAPP) hernia repair using LiquiBand FIX8® or control device.
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 and will be confirmed by ultrasound imaging following physical examination.
To compare the incidence of successful mesh fixation at the time of surgery with LiquiBand FIX8® versus control device.
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.
To compare the incidence of successful peritoneal closure (TAPP repairs only) at the time of surgery for LiquiBand FIX8® versus control device.
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.
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).
Quality of Life will be assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire (a survey used by clinicians and patients to help assess quality of life both pre and post hernia repair) 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.
To compare levels of pain experienced following laparoscopic (TEP and TAPP) groin hernia repair by LiquiBand FIX8® or control device, as measured by VAS.
Evaluation of pain will be measured by VAS (0 = no pain to 10 = most pain imaginable).
To evaluate the safety of LiquiBand FIX8® and control device for groin hernia repair by comparing incidence of adverse events in patients post laparoscopic groin hernia repair.
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.

Full Information

First Posted
June 28, 2019
Last Updated
February 3, 2023
Sponsor
Advanced Medical Solutions Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04009213
Brief Title
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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
November 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Medical Solutions Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal Hernia, Femoral Hernia, Groin Hernia
Keywords
Laparoacopic, Peritoneal Closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to one of two treatment arms, LiquiBand FIX8® or Control (AbsorbaTack™) device at a 1:1 ratio. Subjects will also be randomized according to laparoscopic technique used (TEP or TAPP hernia repair procedure), so that there is appropriate distribution between the Investigational and control devices. Randomization will occur immediately prior to use of either device for mesh fixation (TEP repairs) or mesh fixation and peritoneal closure (TAPP repairs only) and only after the Investigator has laparoscopically inspected the site of repair and determined the patient to be eligible for participation in the study.
Masking
Participant
Masking Description
Randomization to either Investigational or control device will occur at the surgery visit. The patients will be blinded to their randomly assigned treatment device prior to surgery and during the follow up period following surgery. While it is not possible to blind investigators/staff members to the treatment device used, Investigators and staff members will not learn of randomized device until immediately prior to use of device, so as to maintain subject blinding prior to the hernia repair. Investigators and staff members will be asked to maintain subject blinding through the course of the follow up visits so as to not bias subject feedback on applicable study assessments. Patients will receive the same standard of care prior to, during and following surgery regardless of randomized device assignment, and therefore will not be able to individually determine what device they have been randomized to.
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LiquiBand FIX8®
Arm Type
Experimental
Arm Description
LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye
Arm Title
AbsorbaTack™
Arm Type
Active Comparator
Arm Description
AbsorbaTack™ is an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2
Intervention Type
Device
Intervention Name(s)
LiquiBand FIX8®
Intervention Description
An n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye
Intervention Type
Device
Intervention Name(s)
AbsorbaTack™
Intervention Description
An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2.
Primary Outcome Measure Information:
Title
To compare the change 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.
Description
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. The Visual Analog Scale (VAS) consists of a straight line with the endpoints defining extreme limits, 0 = no pain and 10 = worst pain imaginable. The patient is asked to mark his/her pain level on the line between the two endpoints.
Time Frame
Screening from baseline (worst pain experienced within 1 month of screening) and at follow up Day 7, Day 14, Month 1, Month 3, Month 6, Month 9 and Month 12.
Secondary Outcome Measure Information:
Title
To evaluate the incidence of hernia recurrence in patients following laparoscopic (TEP and TAPP) hernia repair using LiquiBand FIX8® or control device.
Description
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 and will be confirmed by ultrasound imaging following physical examination.
Time Frame
Physical examination will take place at 2 weeks, 3 months and 6 months. Suspected hernia recurrence will also be evaluated at any time following surgery and up to the 12 month follow up.
Title
To compare the incidence of successful mesh fixation at the time of surgery with LiquiBand FIX8® versus control device.
Description
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.
Time Frame
At the time of surgery.
Title
To compare the incidence of successful peritoneal closure (TAPP repairs only) at the time of surgery for LiquiBand FIX8® versus control device.
Description
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.
Time Frame
At the time of surgery.
Title
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).
Description
Quality of Life will be assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire (a survey used by clinicians and patients to help assess quality of life both pre and post hernia repair) 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.
Time Frame
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.
Title
To compare levels of pain experienced following laparoscopic (TEP and TAPP) groin hernia repair by LiquiBand FIX8® or control device, as measured by VAS.
Description
Evaluation of pain will be measured by VAS (0 = no pain to 10 = most pain imaginable).
Time Frame
At baseline (pre-surgery), discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months following surgery.
Title
To evaluate the safety of LiquiBand FIX8® and control device for groin hernia repair by comparing incidence of adverse events in patients post laparoscopic groin hernia repair.
Description
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.
Time Frame
Assessments will be intraoperatively, at discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months following surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Roth, Medicine
Organizational Affiliation
University of Kentucky College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
University of Kentucky College of Medicine UK Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Overlake Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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