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Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

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ClinicalTrials.gov Identifier: NCT01665898
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon polyps.

Condition or disease Intervention/treatment
Colon Polyps Procedure: Cold Biopsy forceps Procedure: Cold snare biopsy

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps
Study Start Date : August 2012
Primary Completion Date : August 2014
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665898


Locations
Korea, Republic of
Incheon St. Mary's Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Incheon St.Mary's Hospital
Investigators
Principal Investigator: Bo-In Lee Incheon St.Mary's Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joon Sung Kim, Instructor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01665898     History of Changes
Other Study ID Numbers: IncheonSMH
OC12OISI0067 ( Other Identifier: CMCIRB )
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Joon Sung Kim, Incheon St.Mary's Hospital:
cold biopsy forceps
cold snare biopsy

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps