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Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Subcentimetric Colorectal Polyps: the E-scope (Efficacy and Safety of COld PolypEctomy) Trial
Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality. Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant. Most of the polypectomies are performed for diminutive (\<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps. To minimize the risk of complications when removing \<10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed. Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials. Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy. The investigators perform this study to assess both the efficacy and safety of a novel snare (Exacto™) for polyp removal.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milan, Italy, Italy
San Gerardo Hospital
Monza, Italy
Azienda Ospedaliera "Maggiore della Carità"
Novara, Italy
Start Date
September 1, 2013
Primary Completion Date
April 1, 2014
Completion Date
August 1, 2014
Last Updated
September 22, 2014
250
ACTUAL participants
Exacto™
DEVICE
Lead Sponsor
Istituto Clinico Humanitas
Collaborators
NCT07089615
NCT01368731
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02196649