Back to resultsThe Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
Primary Purpose
Adenoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cap Assisted Colonoscopy
Conventional colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma focused on measuring Screening colonoscopy
Eligibility Criteria
Inclusion Criteria:
- Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.
Exclusion Criteria:
- Patients younger than 18 yrs old or older than 80 yrs.
- Patients with a prior history of colonic surgeries
- Patient with Crohns colitis or ulcerative colitis.
- Patient with prior history of colon cancer
- Patient with poor bowel preparation
Sites / Locations
- Texas Tech University Health Sciences Center at El Paso
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cap Assisted Colonoscopy
Conventional colonoscopy
Arm Description
Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.
A conventional colonoscopy does not use a Cap in order to perform the procedure
Outcomes
Primary Outcome Measures
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
Secondary Outcome Measures
Full Information
NCT ID
NCT01601431
First Posted
May 14, 2012
Last Updated
May 10, 2018
Sponsor
Texas Tech University Health Sciences Center, El Paso
1. Study Identification
Unique Protocol Identification Number
NCT01601431
Brief Title
The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
Official Title
The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Study was inactivated by the IRB since PI left institution.
Study Start Date
March 29, 2012 (Actual)
Primary Completion Date
February 2, 2015 (Actual)
Study Completion Date
February 2, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
Screening colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cap Assisted Colonoscopy
Arm Type
Experimental
Arm Description
Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.
Arm Title
Conventional colonoscopy
Arm Type
Active Comparator
Arm Description
A conventional colonoscopy does not use a Cap in order to perform the procedure
Intervention Type
Device
Intervention Name(s)
Cap Assisted Colonoscopy
Intervention Description
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Intervention Type
Device
Intervention Name(s)
Conventional colonoscopy
Intervention Description
Regular colonoscopy as per standard clinical guidelines
Primary Outcome Measure Information:
Title
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
Description
1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.
Exclusion Criteria:
Patients younger than 18 yrs old or older than 80 yrs.
Patients with a prior history of colonic surgeries
Patient with Crohns colitis or ulcerative colitis.
Patient with prior history of colon cancer
Patient with poor bowel preparation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed O Othman, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center at El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
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