Clinical Trials Directory

Trials / Completed

CompletedNCT02245854

Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
250 (actual)
Sponsor
Istituto Clinico Humanitas · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEExacto™Cold snare polypectomy

Timeline

Start date
2013-09-01
Primary completion
2014-04-01
Completion
2014-08-01
First posted
2014-09-22
Last updated
2014-09-22

Locations

3 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT02245854. Inclusion in this directory is not an endorsement.