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Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 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: February 3, 2017
Last verified: February 2017
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
Intervention Model: Parallel Assignment
Masking: 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 ]
    rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery

Estimated Enrollment: 1750
Actual Study Start Date: September 1, 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)
Sexes Eligible for Study:   All
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
Austin Information Technology Center, Austin, TX Not yet recruiting
Austin, Texas, United States, 78772
Contact: Ranjan Mascarenhas, MD    512-823-4023   
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         
South Texas Health Care System, San Antonio, TX Recruiting
San Antonio, Texas, United States, 78229
Contact: Tisha Lunsford, MD    210-567-4872   
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 ( Other Grant/Funding Number: MERIT )
Study First Received: July 19, 2012
Last Updated: February 3, 2017
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 April 27, 2017