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

NCT02885987 | Withdrawn FDA Device

• 1 other identifier: 5160326
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• ADR will be differentiated according to morphology

  1 week

• ADR will be differentiated according to final pathology

  1 week

• ADR will be differentiated according to location

  1 week

• Advanced ADR

  1 week

• Mean total number of polyps detected

  1 week

Study Arms (2)

Standard Colonoscopy

NO INTERVENTION

AmplifEYE will not be used.

Colonoscopy with AmplifEYE

EXPERIMENTAL

AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure

Device: AmplifEYE

Interventions

AmplifEYE DEVICE

AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.

Also known as: colonoscope accessory device

Colonoscopy with AmplifEYE

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Jahng, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: September 1, 2016
• Study Start: August 3, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)