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decided not to go ahead with study at this time
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The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Colonoscopy | No Intervention | AmplifEYE will not be used. | |
| Colonoscopy with AmplifEYE | Experimental | AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AmplifEYE | Device | AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in adenoma detection rate (ADR), with and without use of AmplifEYE. | ADR is calculated by dividing the total number of screening procedures in which 1 or more histologically confirmed adenomas were detected by the total number of screening procedures performed. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| ADR will be differentiated according to morphology | ADR will be differentiated according to morphology (flat, sessile, pedunculated) | 1 week |
| ADR will be differentiated according to final pathology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Jahng, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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ADR will be differentiated according to final pathology (sessile serrated adenomas, traditional serrated polyps, tubular/villous adenomas)
| 1 week |
| ADR will be differentiated according to location | Location will be specified by colon segment and flexures. | 1 week |
| Advanced ADR | calculated as same for ADR, but only in those with polyps that are >=1 cm in size, with components of villous features, or with those of dysplasia | 1 week |
| Mean total number of polyps detected | calculated by dividing the total number of adenomas detected by the total number of screening procedures performed | 1 week |
| ADR-plus | mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected | 1 week |
| APP (adenomas per positive participant) | calculated as the total number of adenomas detected during the first colonoscopy divided by the number of positive participants (those with ≥1 adenoma detected during the first colonoscopy) | 1 week |
| APC (adenomas per colonoscopy) | calculated as the total number of adenomas detected during the first colonoscopy divided by the number of first colonoscopies | 1 week |
| Quality metrics: time of colonoscopy | Differences in quality metrics will be noted: cecal intubation time and total withdrawal time. | 1 hour |
| Quality metrics: prep quality | Differences in prep quality will be noted | 1 hour |
| Sedative Medications used | Differences in sedative medications used | 1 hour |