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Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

This study is currently recruiting participants.
Verified August 2012 by Incheon St.Mary's Hospital
Sponsor:
Information provided by (Responsible Party):
Joon Sung Kim, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01665898
First received: August 9, 2012
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Colon Polyps
 Procedure: Cold Biopsy forceps
Procedure: Cold snare biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

Resource links provided by NLM:

MedlinePlus related topics: Colonic Polyps
U.S. FDA Resources

Further study details as provided by Incheon St.Mary's Hospital:

Primary Outcome Measures:
  • Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665898

Contacts
Contact: Bo-In Lee, M.D. gidoc4u@gmail.com

Locations
Korea, Republic of
Incheon St. Mary's Hospital Recruiting
Incheon, Korea, Republic of
Contact: Bo-In Lee, M.D.         gidoc4u@gmail.com    
Principal Investigator: Bo-In Lee, M.D.            
Sponsors and Collaborators
Incheon St.Mary's Hospital
  More Information

No publications provided

Responsible Party: Joon Sung Kim, Instructor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01665898     History of Changes
Other Study ID Numbers: IncheonSMH, OC12OISI0067
Study First Received: August 9, 2012
Last Updated: August 15, 2012
Health Authority: Republic of Korea: Incheon St. Mary's Hospital

Keywords provided by Incheon St.Mary's Hospital:
cold biopsy forceps
cold snare biopsy

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

ClinicalTrials.gov processed this record on May 22, 2013