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

GEM SRL15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Gastrointestinal Cancer

Interventions

nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resectionDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, Italy

Outcomes

Primary Outcomes

Evaluate the feasibility of the technique

Appropriateness of ENDONEB medical nebulizer device to apply the surgical haemostatic-sealant Glubran® 2 after gastrointestinal endoscopic resections evaluated in terms of positioning correctly the ENDONEB device for procedure as per the user manual\&#39;s instructions. The outcome is measured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

Time frame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

Evaluate the feasibility of the technique

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.

Time frame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

Secondary Outcomes

Evaluate the ENDONEB Usability and Safety

Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues: • the facility to assembly the device (setting up time, easiness in assembly, single operator assembly). Each point is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

Time frame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

Evaluate the ENDONEB Usability and Safety

Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues: • the ability to deliver the haemostatic-sealant to the resection site. 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.

Data from ClinicalTrials.gov

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