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

Loma Linda University (LLU) logo

Loma Linda University (LLU)

Status

Withdrawn

Conditions

Colonic Polyps

Treatments

Device: AmplifEYE

Study type

Interventional

Funder types

Other

Identifiers

NCT02885987
5160326

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Standard Colonoscopy
No Intervention group
Description:
AmplifEYE will not be used.
Colonoscopy with AmplifEYE
Experimental group
Description:
AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure
Treatment:
Device: AmplifEYE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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