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

Launched by GEM SRL · Sep 5, 2024

Keywords

ClinConnect Summary

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 th...

Gender

ALL

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.