Colonic Polyps
Conditions
Brief summary
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.
Interventions
DEVICEAmplifEYE
AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.
Exclusion criteria
* Any pregnant patient * Patient's that are unable to provide consent for themselves * Any patient undergoing diagnostic colonoscopy (IBD, rectal bleeding, recent change in bowel habits, etc.) * Any patient undergoing surveillance (prior history of polyps or colorectal cancer) * Any patient undergoing high risk screening colonoscopy (family history of colon cancer in first degree family member \<65 years of age, or co-existing conditions that pre-dispose to colon cancer such as polyposis syndromes, PSC or IBD) * Prior history of any cancer * Current or past immunosuppression (due to either infection or medications) * Coagulation disorder OR use of anti-coagulation or anti-platelet therapy other than aspirin within 5-7 days of procedure * Colonic strictures * suspected intestinal obstruction or colonic pseudo-obstruction * history of colon resection * active infection * active inflammation (including diverticulitis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in adenoma detection rate (ADR), with and without use of AmplifEYE. | 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADR will be differentiated according to final pathology | 1 week | ADR will be differentiated according to final pathology (sessile serrated adenomas, traditional serrated polyps, tubular/villous adenomas) |
| ADR will be differentiated according to location | 1 week | Location will be specified by colon segment and flexures. |
| Advanced ADR | 1 week | 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 |
| Mean total number of polyps detected | 1 week | calculated by dividing the total number of adenomas detected by the total number of screening procedures performed |
| ADR-plus | 1 week | mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected |
| ADR will be differentiated according to morphology | 1 week | ADR will be differentiated according to morphology (flat, sessile, pedunculated) |
| APC (adenomas per colonoscopy) | 1 week | calculated as the total number of adenomas detected during the first colonoscopy divided by the number of first colonoscopies |
| Quality metrics: time of colonoscopy | 1 hour | Differences in quality metrics will be noted: cecal intubation time and total withdrawal time. |
| Quality metrics: prep quality | 1 hour | Differences in prep quality will be noted |
| Sedative Medications used | 1 hour | Differences in sedative medications used |
| APP (adenomas per positive participant) | 1 week | 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) |
Countries
United States
Outcome results
None listed