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

NCT02245854 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2014-09-22

No results posted yet for this study

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

  • Polyp of Large Intestine
  • Colonic Polyps
  • Colon Nos Polypectomy Tubular Adenoma
  • Complications
  • Bleeding

Interventions

DEVICE

Exacto™

Cold snare polypectomy

Sponsors & Collaborators

  • San Gerardo Hospital

    collaborator OTHER

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    collaborator OTHER

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Alessandro Repici, MD · Istituto Clinico Humanitas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-04-30
Completion
2014-08-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02245854 on ClinicalTrials.gov