Common Contracts

INVESTIGATOR’S AGREEMENT

Investigator's Agreement • January 9th, 2021

• Contract Type
  Investigator's Agreement
• Filed
  January 9th, 2021

CLINICAL INVESTIGATION SUMMARY‌ Study 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. Investigational Device: LiquiBand FIX8® Hernia Mesh Fixation Device Device Description: The device consists of:a) n-butyl-2-cyanoacrylate adhesive monomer, in liquid form, supplied in a thin-walled, sealed glass vial; and,b) a surgically invasive, laparoscopic 5mm diameter cannula, with a handle at the proximal end incorporating a loading chamber, filter, piston chamber and trigger. The distal tip of the device is open to allow the adhesive to be dispensed from it. The device is designed to be used in conjunction with a 5 mm diameter laparoscopic port sleeve. Both the cyanoacrylate adhesive in the glass vial and the surgically invasive delivery device are supplied sterile, for single use only. Indication for Use: Th