Status:
RECRUITING
Underwater Endoscopic Mucosal Resection
Lead Sponsor:
Instituto Portugues Oncologia de Lisboa Francisco Gentil
Conditions:
Colon Polyp
Adenoma Colon
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The global aim of this multi-centric study is to assess the learning curve of U-EMR by an endoscopist skilled in C-EMR aiming to assess the application in real world and check the rate of complete EMR...
Detailed Description
Conventional Endoscopic mucosal resection (C-EMR) is currently the standard therapy for the removal of large colon polyps. The procedure consists on the injection of fluids into the submucosa layer be...
Eligibility Criteria
Inclusion
- Age: 18 years-old or older with at least one large (\>10 and \<30 mm) non pedunculated polyp
- Agreement with study's procedures, having signed the informed consent for the study and EMR, prior to the procedure
Exclusion
- Previous attempted resection
- Lesion located at ileo-cecal valve or appendiceal orifice
- Fully circumferential lesion
- Pedunculated polyps (Paris classification type Ip) and ulcerated depression lesions (Paris classification type III)
- Surface pattern suggestive of deep invasion (ex: narrow-band imaging (NBI) International Colorectal Endoscopic (NICE) classification type 3 criteria, Kudo V or equivalent)
- Invasive cancer at EMR specimen
- Inflammatory bowel disease
- Familial polyposis syndrome
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06073561
Start Date
January 1 2024
End Date
July 31 2024
Last Update
April 30 2024
Active Locations (1)
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1
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Portugal, 1099-023