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
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Femoral Hernia
- Groin Hernia
- Hernia
- Inguinal Hernia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04009213
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: John S Roth, Medicine University of Kentucky College of Medicine
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