Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: July 19, 2012
Last updated: August 9, 2016
Last verified: August 2016
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
Device: NO 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 VA Office of Research and Development:

Primary Outcome Measures:
  • delayed post polypectomy bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery

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
Other Name: CLIP
Placebo Comparator: No Clip
A hemoclip is not placed at the site of the polypectomy.
Device: NO hemoclip placement
No hemoclip placement (placebo / sham)
Other Name: NO CLIP


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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: Andrew Smith, BA (214) 857-1603

United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Recruiting
Dallas, Texas, United States, 75216
Contact: Andrew Smith, BA    214-857-1603   
Principal Investigator: Linda A Feagins         
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Linda A Feagins VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT01647581     History of Changes
Other Study ID Numbers: CLNB-005-13F  DVAMC-11-026 
Study First Received: July 19, 2012
Last Updated: August 9, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
post-polypectomy bleed

Additional relevant MeSH terms:
Pathologic Processes processed this record on October 26, 2016