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Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00855790
First received: March 2, 2009
Last updated: September 16, 2011
Last verified: January 2010
  Purpose

The purpose of this study is to evaluate the efficacy of the new RJ4 compare with the standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps.


Condition Intervention
Colorectal Polyps
Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Complete endoscopic (visual) eradication of the polyp with the first forceps bite [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of bites to completely visually eradicate the polyp if the polyp was not fully eradicated with the first forceps bite [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Complete pathologic eradication of the polyp on the first forceps bite. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Correlate endoscopic with pathologic eradication [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RJ3 Biopsy Forcep
use of RJ3 Biopsy forcep for the polypectomy
Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep
Use of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm.
Active Comparator: RJ4 Biopsey Forcep
Use of RJ$ biopsy forcep for polypectomy
Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep
Use of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • colon polyps less than 6 mm

Exclusion Criteria:

  • no colon polyps
  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: NCT00855790

Locations
United States, Florida
Shands Endocopy Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter Draganov, MD University of Florida
  More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00855790     History of Changes
Other Study ID Numbers: colon polypectomy
Study First Received: March 2, 2009
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
evaluate the effectiveness of one bite polypectomy with the RJ3 biopsy forcep versus the RJ4 biopsy forcep

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 27, 2014