Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Department of Veterans Affairs
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: July 19, 2012
Last updated: October 10, 2014
Last verified: October 2014

A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.

Condition Intervention
Post-polypectomy Bleeding
Elective Colonoscopy
Device: Hemoclip Placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping

Resource links provided by NLM:

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 1750
Study Start Date: September 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clip
A clip is been placed at the polypectomy site.
Device: Hemoclip Placement
Placement of hemoclip at polypectomy site for polyps at least 1cm in size
Placebo Comparator: No Clip
A hemoclip is not placed at the site of the polypectomy.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients presenting for elective colonoscopy

Exclusion Criteria:

  • Patients in which polypectomy can not be performed safely
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01647581

Contact: Nicholas Rogers, BS (214) 857-3239

United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Recruiting
Dallas, Texas, United States, 75216
Contact: Nicholas Rogers, BS    214-857-3239   
Principal Investigator: Linda Feagins         
Sponsors and Collaborators
Principal Investigator: Linda Feagins VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs Identifier: NCT01647581     History of Changes
Other Study ID Numbers: CLNB-005-13F, DVAMC-11-026
Study First Received: July 19, 2012
Last Updated: October 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
post-polypectomy bleed processed this record on March 02, 2015