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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01647581
First received: July 19, 2012
Last updated: February 3, 2017
Last verified: February 2017
  Purpose
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
Polypectomy
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01647581

Contacts
Contact: Andrew Smith, BA (214) 857-1603 andrew.smith549@va.gov

Locations
United States, Texas
Austin Information Technology Center, Austin, TX Not yet recruiting
Austin, Texas, United States, 78772
Contact: Ranjan Mascarenhas, MD    512-823-4023    ranjan.mascarenhas@va.gov   
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    andrew.smith549@va.gov   
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    lunsfordt@uthscsa.edu   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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
ClinicalTrials.gov Identifier: NCT01647581     History of Changes
Other Study ID Numbers: CLNB-005-13F  DVAMC-11-026 
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:
hemoclip
colonoscopy
post-polypectomy bleed

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on February 20, 2017