Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

March 24, 2015 updated by: Joon Sung Kim, Incheon St.Mary's Hospital

Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon polyps.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Polyps were randomized to be treated with either CSP or CFP. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients older than 40 years old and
  • patients who are receiving colonoscopies and
  • patients who have colon polyps

Exclusion Criteria:

  • patients who have not agreed to the study
  • patients with bleeding tendencies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cold biopsy forceps
Cold biopsy forceps for removal of colon polyps
Procedure: Cold Biopsy forceps
removal of polyps using cold biopsy forceps
Active Comparator: Cold Snare Biopsy
Cold snare biopsy for removal of colon polyps
Procedure: Cold snare biopsy
Removal of colon polyps using cold snare biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps
Time Frame: up to 3 years
We will investigate the complete removal rate of colon polyps by using two different methods, cold biopsy forceps or cold snare biopsy. After removal of polyps by one of these two methods, the remnant lesion will be biopsied to study if there are any remnant tissues in order to find out the complete removal rate.
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy
Time Frame: participants will be followed up for 1 month
We will investigate bleeding rate after removal of colon polyps by these two methods. Bleeding rate will be the number of patients who showed significant bleeding after the procedure divided by the total number of patients who will receive the procedure. Significant bleeding was determined to be ongoing bleeding for more than 30 seconds after the procedure
participants will be followed up for 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incheon St.Mary's Hospital

Investigators

  • Principal Investigator: Bo-In Lee, Incheon St.Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IncheonSMH
  • OC12OISI0067 (Other Identifier: CMCIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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