Clinical trial NCT04009213: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Inguinal Hernia
Femoral Hernia
Groin Hernia
Keywords: Laparoacopic
Peritoneal Closure
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 284
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in Pain
timeFrame: 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:
measure: Number of Participants With Hernia Recurrence
timeFrame: Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported
measure: Successful Mesh Fixation at the Time of Surgery.
timeFrame: Time of surgery.
measure: Incidence of Successful Peritoneal Closure (TAPP Repairs Only)
timeFrame: Time of surgery.
measure: Quality of Life as Measured by the Carolinas Comfort Scale (CCS).
timeFrame: Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
measure: Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).
timeFrame: 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
measure: Safety as Measured by the Incidence of Adverse Events.
timeFrame: Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Lexington
country: United States
facility: University of Kentucky College of Medicine UK Medical Center
state: Kentucky
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Bellevue
country: United States
facility: Overlake Medical Center
state: Washington
Study officials:
affiliation: University of Kentucky College of Medicine
name: John S Roth, Medicine
role: PRINCIPAL_INVESTIGATOR
References: