Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01647581
First received: July 19, 2012
Last updated: March 27, 2014
Last verified: March 2014
  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

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:

Primary Outcome Measures:
  • delayed post polypectomy bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1600
Study Start Date: September 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Locations
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Nicholas Rogers, BS    214-857-3239    Nicholas.Rogers2@va.gov   
Principal Investigator: Linda A Feagins, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Linda A Feagins, MD Dallas VAMC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
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: March 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hemoclip
colonoscopy
post-polypectomy bleed

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014