Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588881
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran 2 Usability Trial in EMR and ESD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Glubran2 in nebulized form in laparotomic laparoscopic and thoracoscopic procedures The ENDONEB medical device allows to apply the Glubran2 in nebulized form in digestive endoscopy interventions and can be used both with gastroscopes and colonoscopes with an operating channel not less than 26 mm It is marketed in sterile presentation the components are latex free and is for single use only
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 Glubran2 in nebulized form in laparotomic laparoscopic and thoracoscopic procedures The ENDONEB medical device allows to apply the Glubran2 in nebulized form in digestive endoscopy interventions and can be used both with gastroscopes and colonoscopes with an operating channel not less than 26 mm It is marketed in sterile presentation the components are latex free and is for single use only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None