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

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ClinicalTrials.gov Identifier: NCT02885987
Recruitment Status : Withdrawn (decided not to go ahead with study at this time)
First Posted : September 1, 2016
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Alexander Jahng, MD, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Device: AmplifEYE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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 Name: colonoscope accessory device




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. ADR will be differentiated according to morphology [ Time Frame: 1 week ]
    ADR will be differentiated according to morphology (flat, sessile, pedunculated)

  2. 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)

  3. ADR will be differentiated according to location [ Time Frame: 1 week ]
    Location will be specified by colon segment and flexures.

  4. 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

  5. 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

  6. ADR-plus [ Time Frame: 1 week ]
    mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected

  7. 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)

  8. 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

  9. Quality metrics: time of colonoscopy [ Time Frame: 1 hour ]
    Differences in quality metrics will be noted: cecal intubation time and total withdrawal time.

  10. Quality metrics: prep quality [ Time Frame: 1 hour ]
    Differences in prep quality will be noted

  11. Sedative Medications used [ Time Frame: 1 hour ]
    Differences in sedative medications used



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885987


Locations
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United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Alexander Jahng, MD Loma Linda University
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Responsible Party: Alexander Jahng, MD, Assistant Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT02885987    
Other Study ID Numbers: 5160326
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical