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Study was inactivated by the IRB since PI left institution.
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cap Assisted Colonoscopy | Experimental | 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. |
|
| Conventional colonoscopy | Active Comparator | A conventional colonoscopy does not use a Cap in order to perform the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cap Assisted Colonoscopy | Device | Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed O Othman, MD | Texas Tech University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center at El Paso | El Paso | Texas | 79905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cap Assisted Colonoscopy | 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. Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate |
| FG001 | Conventional Colonoscopy | A conventional colonoscopy does not use a Cap in order to perform the procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cap Assisted Colonoscopy | 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. Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cap Assisted Colonoscopy | 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. Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders | Systematic Assessment |
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single center study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Othman, M.D. | Baylor College of Medicine | 713 798 0947 | mohamed.othman@bcm.edu |
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| ID | Term |
|---|---|
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Conventional colonoscopy | Device | Regular colonoscopy as per standard clinical guidelines |
|
| BG001 |
| Conventional Colonoscopy |
A conventional colonoscopy does not use a Cap in order to perform the procedure Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Adenoma Detection Rate | Count of Participants | Participants |
|
| Polyp detection rate | Count of Participants | Participants |
|
| Advanced adenoma detection rate | Count of Participants | Participants |
|
|
|
| 0 |
| 211 |
| 1 |
| 211 |
| 0 |
| 211 |
| EG001 | Conventional Colonoscopy | A conventional colonoscopy does not use a Cap in order to perform the procedure Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines | 0 | 214 | 0 | 214 | 0 | 214 |
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