Status:
COMPLETED
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
Lead Sponsor:
GEM SRL
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 recomand...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06588881
Start Date
March 14 2023
End Date
March 28 2024
Last Update
September 19 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, Italy