Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
- Conditions
- Colonic Polyps
- Interventions
- Device: AmplifEYE
- Registration Number
- NCT02885987
- Lead Sponsor
- Loma Linda University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colonoscopy with AmplifEYE AmplifEYE AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ADR will be differentiated according to morphology 1 week ADR will be differentiated according to morphology (flat, sessile, pedunculated)
Sedative Medications used 1 hour Differences in sedative medications used
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)
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
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 location 1 week Location will be specified by colon segment and flexures.
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)
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
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
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
Trial Locations
- Locations (1)
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States