NCT02201147

Brief Summary

The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

July 22, 2014

Last Update Submit

May 2, 2015

Conditions

Polyp of Large Intestine

Outcome Measures

Primary Outcomes (1)

  • complete histologic polyp eradication rate

    2 weeks

Secondary Outcomes (1)

  • rates of tissue retrieval per polyp

    2 weeks

Other Outcomes (1)

  • polypectomy procedure times

    2 weeks

Study Arms (2)

cold biopsy polypectomy

EXPERIMENTAL
Procedure: Cold biopsy polypectomyDevice: Cold biopsy polypectomy

Cold snare polypectomy

EXPERIMENTAL
Procedure: Cold snare polypectomyDevice: Cold snare polypectomy

Interventions

Cold biopsy polypectomyPROCEDURE

removal of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy

cold biopsy polypectomy
Cold snare polypectomyPROCEDURE

removal of eligible polyps using cold snare polypectomy technique

Cold snare polypectomy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over the age of 20 years undergoing routine colonoscopy (screening, surveillance, or diagnostic)

You may not qualify if:

  • patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
  • known coagulopathy
  • history of inflammatory bowel diseases
  • American Society of Anesthesiology class III or more
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonchunhyang University Hospital, Bucheon

Bucheon-si, 420-767, South Korea

Location

Related Publications (1)

  • Park SK, Ko BM, Han JP, Hong SJ, Lee MS. A prospective randomized comparative study of cold forceps polypectomy by using narrow-band imaging endoscopy versus cold snare polypectomy in patients with diminutive colorectal polyps. Gastrointest Endosc. 2016 Mar;83(3):527-32.e1. doi: 10.1016/j.gie.2015.08.053. Epub 2015 Sep 7.

    PMID: 26358331DERIVED

Study Officials

  • Bong Min Ko, MD

    SoonChunHyang University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 25, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

KR(1)