Clinical trial NCT06588881: Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: GEM SRL
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Single center, prospective, medical device usability and feasibility study.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Evaluate the feasibility of the technique
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
measure: Evaluate the feasibility of the technique
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
Secondary outcomes:
measure: Evaluate the ENDONEB Usability and Safety
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
measure: Evaluate the ENDONEB Usability and Safety
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
measure: Evaluate the ENDONEB Usability and Safety
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
measure: Evaluate the ENDONEB Usability and Safety
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
measure: Evaluate the ENDONEB Usability and Safety
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
measure: Evaluate the ENDONEB Usability and Safety
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
measure: Evaluate the ENDONEB Usability and Safety
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
measure: Evaluate the ENDONEB Usability and Safety
timeFrame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Cristiano Spada, DR
role: PRINCIPAL_INVESTIGATOR
References: