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

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.

Study Overview

• Status: Withdrawn
• Conditions: Colonic Polyps
• Intervention / Treatment: Device: AmplifEYE

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard Colonoscopy; AmplifEYE will not be used.
EXPERIMENTAL: Colonoscopy with AmplifEYE; AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure	Device: AmplifEYE; AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.; Other Names: colonoscope accessory device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Alexander Jahng, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2017
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (ESTIMATE): September 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: 5160326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes