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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gastrointestinal Cancer
- Sponsor
- GEM SRL
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Evaluate the feasibility of the technique
- Status
- Completed
- Last Updated
- last year
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of superficial neoplastic lesion to be resected by a gastrointestinal endoscopic resection (EMR or ESD)
- •Older than 18 years of age at time of consent;
- •Operable per institution's standards;
- •Signed and dated informed consent form
Exclusion Criteria
- •Any clinical conditions precluding the feasibility of gastrointestinal endoscopic resection (ENDONEB could be contraindicated in patients who are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment);
- •Pregnant during period of study participation;
- •Allergy history to cyanoacrylate.
Outcomes
Primary Outcomes
Evaluate the feasibility of the technique
Time Frame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
Appropriateness of ENDONEB medical nebulizer device to apply the surgical haemostatic-sealant Glubran® 2 after gastrointestinal endoscopic resections evaluated in terms of facility of use and satisfaction/effectiveness of the surgeon. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.
Secondary Outcomes
- Evaluate the ENDONEB Usability and Safety(From the beginning of the surgery until the end of surgery. Approximately 3 hours.)