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

NCT ID: NCT02885987

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2022-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Standard Colonoscopy

AmplifEYE will not be used.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Colonoscopy with AmplifEYE

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

Group Type: EXPERIMENTAL

AmplifEYE

Intervention Type: DEVICE

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

Interventions

AmplifEYE

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

Intervention Type: DEVICE

Other Intervention Names

colonoscope accessory device

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Alexander Jahng, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Jahng, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

Countries

United States

Other Identifiers

5160326

Identifier Type: -

Identifier Source: org_study_id