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

NCT06588881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-19

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection

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.

Sponsors & Collaborators

  • GEM SRL

    lead INDUSTRY

Principal Investigators

  • Cristiano Spada, DR · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2024-03-28
Completion
2024-03-28

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06588881 on ClinicalTrials.gov