Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery

NACompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

October 19, 2020

Primary Completion Date

June 29, 2023

Study Completion Date

June 29, 2023

Conditions
Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

58100

Ospedale Misericordia - U.O.C Chirurgia Generale e Mini-Invasiva., Grosseto

All Listed Sponsors
lead

GEM SRL

INDUSTRY

NCT06462066 - Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery | Biotech Hunter | Biotech Hunter