Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

This study is currently recruiting participants.
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
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 April 17, 2014