Viewing Study NCT01601431



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Last Modification Date: 2024-10-26 @ 10:51 AM
Study NCT ID: NCT01601431
Status: TERMINATED
Last Update Posted: 2018-06-07
First Post: 2012-05-14

Brief Title: The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
Sponsor: Texas Tech University Health Sciences Center El Paso
Organization: Texas Tech University Health Sciences Center El Paso

Study Overview

Official Title: The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
Status: TERMINATED
Status Verified Date: 2018-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Study was inactivated by the IRB since PI left institution
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a research study about the usefulness of transparent cap during screening colonoscopy The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps polyps which can become colon cancer later on in comparison to the standard colonoscopy
Detailed Description: This is a prospective randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy The aims of the study are

1 Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap
2 Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap
3 Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy
4 Compare the complication rate between standard colonoscopy and cap assisted colonoscopy

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None