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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

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ClinicalTrials.gov Identifier: NCT04009213
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Advanced Medical Solutions Ltd.

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).

Condition or disease Intervention/treatment Phase
Hernia Inguinal Hernia Femoral Hernia Groin Hernia Device: LiquiBand FIX8® Device: AbsorbaTack™ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: LiquiBand FIX8®
LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye
Device: LiquiBand FIX8®
An n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye

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




Primary Outcome Measures :
  1. 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. [ Time Frame: Screening from baseline (worst pain experienced within 1 month of screening) and at follow up Day 7 (by telephone), Day 14 (in clinic), Month 1(by telephone), Month 3 (in clinic), Month 6 (in clinic), Month 9 (by telephone), Month 12 (by telephone). ]
    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 :
  1. To evaluate the incidence of hernia recurrence in patients following laparoscopic (TEP and TAPP) hernia repair using LiquiBand FIX8® or control device. [ 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. ]
    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.

  2. To compare the incidence of successful mesh fixation at the time of surgery with LiquiBand FIX8® versus control device. [ Time Frame: At the time of surgery. ]
    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.

  3. To compare the incidence of successful peritoneal closure (TAPP repairs only) at the time of surgery for LiquiBand FIX8® versus control device. [ Time Frame: At the time of surgery. ]
    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.

  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). [ 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. ]
    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.

  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. [ 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. ]
    Evaluation of pain will be measured by VAS (0 = no pain to 10 = most pain imaginable).

  6. 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. [ 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. ]
    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.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009213


Contacts
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Contact: Tina Warburton 01606 863500 ext 8007 tina.warburton@admedsol.com
Contact: Jason Alarcon 919-397-1030 jason.alarcon@admedsol.com

Locations
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United States, Kentucky
University of Kentucky College of Medicine UK Medical Center Recruiting
Lexington, Kentucky, United States, 40506
Contact: Roth    859-257-9428    s.roth@uky.edu   
Principal Investigator: John S Roth         
Sub-Investigator: Crystal Totten         
Sub-Investigator: Henrik Berdel         
Sub-Investigator: Andrew Bernard         
Sub-Investigator: William Cavatassi         
Sub-Investigator: Jessica Reynolds         
Sub-Investigator: Zachary Warriner         
Sub-Investigator: Anthony Bottiggi         
Sub-Investigator: Brian Tucker         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michael Rosen    216-445-3441    rosenm@ccf.org   
Principal Investigator: Michael Rosen         
Sub-Investigator: Steven Rosenblatt         
Sub-Investigator: Ajita Prabhu         
Sub-Investigator: David Krapata         
Sub-Investigator: Clayton Petro         
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Narula    614-366-9273    Raja.narula@osumc.edu   
Principal Investigator: Vimal K Narula         
Sub-Investigator: Benjamin Poulose         
Sub-Investigator: Kelly Haisley         
United States, South Carolina
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Alfredo M Carbonell    864-455-5995    acarbonell@ghs.org   
Contact: Jeremy Warren    (864) 676-1072    jwarren1@ghs.org   
Principal Investigator: Alfredo M Carbonell         
Sub-Investigator: Jeremy Warren         
United States, Washington
Overlake Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Adel El-Ghazzawy    425-688-1916    a.el-ghazzawy@proliancesurgeons.com   
Principal Investigator: Adel El-Ghazzawy         
Sponsors and Collaborators
Advanced Medical Solutions Ltd.
Investigators
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Principal Investigator: John S Roth, Medicine University of Kentucky College of Medicine
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Responsible Party: Advanced Medical Solutions Ltd.
ClinicalTrials.gov Identifier: NCT04009213    
Other Study ID Numbers: LBF8-01 Version 1.2a
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Advanced Medical Solutions Ltd.:
Laparoacopic
Peritoneal Closure
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Hernia, Femoral
Pathological Conditions, Anatomical
Hernia, Abdominal