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
Purpose
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
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- 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.
- Primary Purpose
- Treatment
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental LiquiBand FIX8® |
LiquiBand FIX8® is 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 |
|
Recruiting Locations
More Details
- NCT ID
- NCT04009213
- Status
- Completed
- Sponsor
- Advanced Medical Solutions Ltd.