NCT06588881

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

A Pilot Study on Feasibility of Technique, Performance and Safety of ENDONEB Endoscopic Medical Device for the Nebulized Application of the Haemostatic Surgical Sealant After Gastrointestinal Endoscopic Resection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: GEM SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.

Detailed description

Single center, prospective, medical device usability and feasibility study. The study will be performed in Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome. According to the recomandations of the Italian Ministry of Health (28) regarding the sample size of pilot and feasibility studies, 15 applications underwent to mucosal or submucosal resection procedures will be evaluated. The recruitment period will be 36 weeks (9 months). The evaluation ends when ENDONEB has been used in the fifteenth subject or at one third of applications if the investigators will be able to give their evaluation of the feasibility of the ENDONEB technique, usability and safety. The ENDONEB medical device belongs to the family of "Nebulizers" class IIa accessory devices, used to apply Glubran®2 in nebulized form in laparotomic, laparoscopic and thoracoscopic procedures. The ENDONEB medical device allows to apply the Glubran®2 in nebulized form in digestive endoscopy interventions and can be used both with gastroscopes and colonoscopes with an operating channel not less than 2.6 mm. It is marketed in sterile presentation; the components are latex free and is for single use only.

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-14
• Primary completion: 2024-03-28
• Completion: 2024-03-28
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy