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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009213
• Other study ID #: LBF8-01 Version 1.3
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: November 23, 2022

Study information

• Verified date: January 2024
• Source: Advanced Medical Solutions Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: November 23, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Hernia
• Groin Hernia
• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• LiquiBand FIX8®
An n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye
• AbsorbaTack™
An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2.

Locations

Country	Name	City	State
United States	Overlake Medical Center	Bellevue	Washington
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	University of Kentucky College of Medicine UK Medical Center	Lexington	Kentucky
United States	Cleveland Clinic	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Medical Solutions Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Hernia Recurrence	The incidence of hernia recurrence was assessed by physical examination and confirmed by ultrasound imaging following physical examination. Also, the study sites were guided to ask the subjects 3 questions during the clinic visit performed remotely with a 'Yes' or 'No' response; 1. Do you think your hernia has come back? 2. Do you feel or see a bulge? and 3. Do you have physical pain or symptoms at the site?	Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported
Secondary	Successful Mesh Fixation at the Time of Surgery.	LiquiBand FIX8® was required to successfully fix hernia mesh at a rate non-inferior to control device (AbsorbaTack™). Successful mesh fixation did not require any additional fixation by alternate fixation device.	Time of surgery.
Secondary	Incidence of Successful Peritoneal Closure (TAPP Repairs Only)	LiquiBand FIX8® was required to successfully approximate the peritoneum at a rate non-inferior to control device. Successful peritoneal closure did not require any additional fixation by alternate fixation device or additional procedure.	Time of surgery.
Secondary	Quality of Life as Measured by the Carolinas Comfort Scale (CCS).	Quality of Life was assessed by completion of the Carolinas Comfort Scale (CCS) Questionnaire. CCS scores at each timepoint were compared between the LiquiBand FIX8® and control (AbsorbaTack) treatment groups. Carolinas Comfort Scale measures quality of life through a 23-item, Likert-type questionnaire that measures severity of pain, sensation of mesh and movement limitations in eight categories: laying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking, stairs and exercise. The subscales scores for pain (0-40), sensation of mesh (0-40) and movement limitations (0-35) are combined to provide a total CCS score. The best possible score is 0 and the worst possible score is 115.	Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Secondary	Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).	A Visual Analog Scale (VAS) was used as a measure of pain where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.	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
Secondary	Safety as Measured by the Incidence of Adverse Events.	The number of all adverse events whether or not determined to be related to the LiquiBand FIX8® device or control device (AbsorbaTack™).	Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery