Study Stopped
Study was inactivated by the IRB since PI left institution.
The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
1 other identifier
interventional
440
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2012
CompletedFirst Submitted
Initial submission to the registry
May 14, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2015
CompletedResults Posted
Study results publicly available
June 7, 2018
CompletedJune 7, 2018
May 1, 2018
2.8 years
May 14, 2012
May 15, 2017
May 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (2)
Cap Assisted Colonoscopy
EXPERIMENTALCap 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.
Conventional colonoscopy
ACTIVE COMPARATORA conventional colonoscopy does not use a Cap in order to perform the procedure
Interventions
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Regular colonoscopy as per standard clinical guidelines
Eligibility Criteria
You may qualify if:
- Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, 79905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
single center study
Results Point of Contact
- Title
- Mohamed Othman, M.D.
- Organization
- Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed O Othman, MD
Texas Tech University Health Sciences Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 14, 2012
First Posted
May 18, 2012
Study Start
March 29, 2012
Primary Completion
February 2, 2015
Study Completion
February 2, 2015
Last Updated
June 7, 2018
Results First Posted
June 7, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share