101
Participants
Start Date
October 19, 2020
Primary Completion Date
June 29, 2023
Study Completion Date
June 29, 2023
Experimental medical device
Open the blister and pour the sterile single-dose bottle onto the operating table in a sterile field. Before opening the single-dose bottle verify the state of fluidity of the glue and its transparency. Open the single dose of Gluban Tiss® 2. Insert the transfer tip on the single dose, grabbing it near the neck to apply adequate pressure that allows the insertion of the tip. Gradually fill the cartridge by carefully pressing on the body of the single dose.
Comparator medical device
Open the blister and pour the sterile single-dose bottle onto the operating table in a sterile field. Before opening the single-dose bottle verify the state of fluidity of the glue and its transparency. Open the single dose of Glubran® 2. Insert the transfer tip on the single dose, grabbing it near the neck to apply adequate pressure that allows the insertion of the tip. Gradually fill the cartridge by carefully pressing on the body of the single dose.
Ospedale Misericordia - U.O.C Chirurgia Generale e Mini-Invasiva., Grosseto
GEM SRL
INDUSTRY