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

NCT04009213 | Completed Results FDA Device

• 1 other identifier: LBF8-01 Version 1.3
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 6

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).

Conditions

Hernia; Inguinal Hernia; Femoral Hernia; Groin Hernia

Keywords

Laparoacopic; Peritoneal Closure

Outcome Measures

Primary Outcomes (1)

• Change in Pain

  Change in pain from baseline to 6 month will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.

  Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.

Secondary Outcomes (6)

• Number of Participants With Hernia Recurrence

  Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported

• Successful Mesh Fixation at the Time of Surgery.

  Time of surgery.

• Incidence of Successful Peritoneal Closure (TAPP Repairs Only)

  Time of surgery.

• Quality of Life as Measured by the Carolinas Comfort Scale (CCS).

  Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery

• Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).

  Evaluation of pain will be measured at pre-surgery, discharge (up to 3 days), Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery

Study Arms (2)

LiquiBand FIX8®

EXPERIMENTAL

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

Device: LiquiBand FIX8®

AbsorbaTack™

ACTIVE COMPARATOR

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

Device: AbsorbaTack™

Interventions

LiquiBand FIX8® DEVICE

An n-butyl-2-cyanoacrylate adhesive monomer and D\&C Violet #2 dye

LiquiBand FIX8®

AbsorbaTack™ DEVICE

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

AbsorbaTack™

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• D Max™ Mesh (Bard Inc.)
• D 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead

Study Sites (6)

Cleveland Clinic

Weston, Florida, 33331, United States

Location

University of Kentucky College of Medicine UK Medical Center

Lexington, Kentucky, 40506, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Overlake Medical Center

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Hernia; Hernia, Inguinal; Hernia, Femoral

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal

Results Point of Contact

• Title: Tina Warburton, Senior Clinical Research Associate
• Organization: Advanced Medical Solutions

tina.warburton@admedsol.com

07791742957

Study Officials

• John S Roth, Medicine

  University of Kentucky College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 5, 2019
• Study Start: August 22, 2019
• Primary Completion: June 13, 2022
• Study Completion: November 23, 2022
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)