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

Not Applicable

Completed

• Conditions: Gastrointestinal Cancer
• Interventions: Device: nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection

• Registration Number: NCT06588881
• Lead Sponsor: GEM SRL

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.

Study Timeline

• Study Start: 2023-03-14
• Primary Completion: 2024-03-28
• Study Completion: 2024-03-28
• Study First Submitted: 2024-08-07
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ENDONEB	nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection	The sterile device and gamma rays, latex free and disposable consists of the following components: a steel canister, a catheter 2m hose, one attack base located at the proximal end of the catheter, one unit at the end back, two needles and two syringes. The device must always be stored in the original packaging. Store only in one place Temp temperature not exceeding 30°C(86°)Application procedure: The device must be pr repaired and activated adequately in order to ensure its correctness operation. See instructions for assembly and indoor use of the package.

Primary Outcome Measures

Name	Time	Method
Evaluate the feasibility of the technique	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 Outcome Measures

Name	Time	Method
Evaluate the ENDONEB Usability and Safety	From the beginning of the surgery until the end of surgery. Approximately 3 hours.	Safety assessment will be performed by verifying any episodes of device malfunction during the entire application such as: • lengthening of application times due to obstruction of the catheter or obstruction of the operating channel. The outcome is measured with a score from 1 to 5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy