Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate

Study Overview
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Brief Summary
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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.

Official Title
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Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate

Conditions
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Colonic Polyps

Intervention / Treatment
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* Device: AmplifEYE


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Colonoscopy<br>AmplifEYE will not be used. | |
| Experimental: Colonoscopy with AmplifEYE<br>AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure | Device: AmplifEYE<br>* AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.<br>* Other names: colonoscope accessory device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |