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Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

This study is currently recruiting participants.
Verified July 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT01647581
First Posted: July 23, 2012
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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: Single (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 3, 2018
Estimated Primary Completion Date: December 3, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647581


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

Locations
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    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   
Central Texas Veterans Health Care System, Temple, TX Recruiting
Temple, Texas, United States, 76504
Contact: Ranjan Mascarenhas, MD    512-823-4023    ranjan.mascarenhas@va.gov   
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 ( Other Grant/Funding Number: MERIT )
First Submitted: July 19, 2012
First Posted: July 23, 2012
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes