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

Fecha de inicio: 22 de agosto de 2019

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