Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

Colon Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665898
• Other study ID #: IncheonSMH
• Secondary ID: OC12OISI0067
• Status: Completed
• Phase: N/A
• First received: August 9, 2012
• Last updated: March 24, 2015
• Start date: August 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Incheon St.Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Polyps
• Colonic Polyps
• Polyps

Intervention

Procedure:
• Cold Biopsy forceps
removal of polyps using cold biopsy forceps
• Cold snare biopsy
Removal of colon polyps using cold snare biopsy

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps	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	Yes
Secondary	Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy	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	Yes