Back to resultsComparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter
Primary Purpose
Colorectal Polyps
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Polyps focused on measuring evaluate the effectiveness of one bite polypectomy with the RJ3 biopsy forcep versus the RJ4 biopsy forcep
Eligibility Criteria
Inclusion Criteria:
- colon polyps less than 6 mm
Exclusion Criteria:
- no colon polyps
Sites / Locations
- Shands Endocopy Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
RJ3 Biopsy Forcep
RJ4 Biopsey Forcep
Arm Description
use of RJ3 Biopsy forcep for the polypectomy
Use of RJ$ biopsy forcep for polypectomy
Outcomes
Primary Outcome Measures
Complete endoscopic (visual) eradication of the polyp with the first forceps bite
Secondary Outcome Measures
Number of bites to completely visually eradicate the polyp if the polyp was not fully eradicated with the first forceps bite
Complete pathologic eradication of the polyp on the first forceps bite.
Correlate endoscopic with pathologic eradication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00855790
Brief Title
Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyps
Keywords
evaluate the effectiveness of one bite polypectomy with the RJ3 biopsy forcep versus the RJ4 biopsy forcep
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RJ3 Biopsy Forcep
Arm Type
Active Comparator
Arm Description
use of RJ3 Biopsy forcep for the polypectomy
Arm Title
RJ4 Biopsey Forcep
Arm Type
Active Comparator
Arm Description
Use of RJ$ biopsy forcep for polypectomy
Intervention Type
Other
Intervention Name(s)
evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep
Intervention Description
Use of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm.
Primary Outcome Measure Information:
Title
Complete endoscopic (visual) eradication of the polyp with the first forceps bite
Time Frame
one year
Secondary Outcome Measure Information:
Title
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
Title
Complete pathologic eradication of the polyp on the first forceps bite.
Time Frame
one year
Title
Correlate endoscopic with pathologic eradication
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
colon polyps less than 6 mm
Exclusion Criteria:
no colon polyps
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Draganov, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands Endocopy Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22196811
Citation
Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.
Results Reference
derived
Learn more about this trial
Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter
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