Colorectal Polyps Clinical Trial
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
Verified date | July 2015 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - colon polyps less than 6 mm Exclusion Criteria: - no colon polyps |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Shands Endocopy Center | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete endoscopic (visual) eradication of the polyp with the first forceps bite | one year | No | |
Secondary | Number of bites to completely visually eradicate the polyp if the polyp was not fully eradicated with the first forceps bite | one year | No | |
Secondary | Complete pathologic eradication of the polyp on the first forceps bite. | one year | No | |
Secondary | Correlate endoscopic with pathologic eradication | one year | No |
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