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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Loma Linda University

Current Primary Outcome: Difference in adenoma detection rate (ADR), with and without use of AmplifEYE. [ Time Frame: 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.


Original Primary Outcome: Difference in adenoma detection rate (ADR), with and without use of Endocuff. [ Time Frame: 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.


Current Secondary Outcome:

  • ADR will be differentiated according to morphology [ Time Frame: 1 week ]
    ADR will be differentiated according to morphology (flat, sessile, pedunculated)
  • ADR will be differentiated according to final pathology [ Time Frame: 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 [ Time Frame: 1 week ]
    Location will be specified by colon segment and flexures.
  • Advanced ADR [ Time Frame: 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 [ Time Frame: 1 week ]
    calculated by dividing the total number of adenomas detected by the total number of screening procedures performed
  • ADR-plus [ Time Frame: 1 week ]
    mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected
  • APP (adenomas per positive participant) [ Time Frame: 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)
  • APC (adenomas per colonoscopy) [ Time Frame: 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 [ Time Frame: 1 hour ]
    Differences in quality metrics will be noted: cecal intubation time and total withdrawal time.
  • Quality metrics: prep quality [ Time Frame: 1 hour ]
    Differences in prep quality will be noted
  • Sedative Medications used [ Time Frame: 1 hour ]
    Differences in sedative medications used


Original Secondary Outcome: Same as current

Information By: Loma Linda University

Dates:
Date Received: July 8, 2016
Date Started: April 2017
Date Completion: March 2022
Last Updated: April 12, 2017
Last Verified: April 2017