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

Completed · Not applicable

Conditions studied: Hernia, Inguinal Hernia, Femoral Hernia, Groin Hernia

In brief

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).

Key facts

Study ID

NCT04009213

Run by

Advanced Medical Solutions Ltd.

People needed

284

Starts

2019-08-22

Expected to finish

2022-11-23

Last updated by the study team

2024-01-11

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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;
• 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

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
• 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

Where it is running

• Cleveland Clinic — Weston, Florida, United States
• University of Kentucky College of Medicine UK Medical Center — Lexington, Kentucky, 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
• Overlake Medical Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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