Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 14, 2023

Primary Completion Date

March 28, 2024

Study Completion Date

March 28, 2024

Conditions
Gastrointestinal Cancer
Interventions
DEVICE

nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection

ENDONEB, a nebulizing catheter containing the synthetic haemostatic-sealant Glubran®, is inserted in the operative channel of the endoscope until it is pushed out of the endoscope tip approximately 2 cm. The haemostatic-sealant is nebulized over the surface of the post resection mucosal defect by activating the propellant (medical-inert-gas) container. An amount of about 0.3 mL of Glubran® 2 (or more - depending on dimension of the lesion) is applied on mucosal or sub-mucosal defect in order to create a proper haemostaticsealant film.

Trial Locations (1)

Unknown

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

All Listed Sponsors
lead

GEM SRL

INDUSTRY