The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps

Postpolypectomy Bleeding Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036047
• Other study ID #: Exacto
• Status: Completed
• Phase: N/A
• First received: January 11, 2014
• Last updated: November 2, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal polyps, resulting in an increase in the complete resection rate and a decrease in the adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with colorectal polyps up to 10 mm in diameter.

Exclusion Criteria:

• patients are less than 20 years old, pregnant, ASA class III and IV, allergic to propofol used or its components (soybeans or eggs), with poor bowel preparation, and with previous colorectal surgical resection.

Study Design

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

Related Conditions & MeSH terms

• Cold Snare Polypectomy
• Complete Resection Rate
• Diminutive Colorectal Polyp
• Polypectomy Snare
• Postpolypectomy Bleeding

Intervention

Device:
• exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)

• Regular polypectomy snare (Snare Master, SD-210U-10)

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The procedure time	The procedure time spent for cold snare polypectomy	1 day	No
Primary	Complete resection rate of colorectal polyps	The complete resection rate of colorectal polyps based on the pathological examination.	2 weeks	No
Secondary	Postpolypectomy bleeding	Postpolypectomy bleeding within two weeks after cold snare polypectomy	2 weeks	Yes