Back to resultsUse of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
Primary Purpose
Colonic Polyps
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AmplifEYE
Sponsored by
About this trial
This is an interventional screening trial for Colonic Polyps
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)
Sites / Locations
- Loma Linda University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Colonoscopy
Colonoscopy with AmplifEYE
Arm Description
AmplifEYE will not be used.
AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
ADR will be differentiated according to morphology
ADR will be differentiated according to morphology (flat, sessile, pedunculated)
ADR will be differentiated according to final pathology
ADR will be differentiated according to final pathology (sessile serrated adenomas, traditional serrated polyps, tubular/villous adenomas)
ADR will be differentiated according to location
Location will be specified by colon segment and flexures.
Advanced ADR
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
calculated by dividing the total number of adenomas detected by the total number of screening procedures performed
ADR-plus
mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected
APP (adenomas per positive participant)
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)
calculated as the total number of adenomas detected during the first colonoscopy divided by the number of first colonoscopies
Quality metrics: time of colonoscopy
Differences in quality metrics will be noted: cecal intubation time and total withdrawal time.
Quality metrics: prep quality
Differences in prep quality will be noted
Sedative Medications used
Differences in sedative medications used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02885987
Brief Title
Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
Official Title
Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
decided not to go ahead with study at this time
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Colonoscopy
Arm Type
No Intervention
Arm Description
AmplifEYE will not be used.
Arm Title
Colonoscopy with AmplifEYE
Arm Type
Experimental
Arm Description
AmplifEYE accessory device will be attached to the colonoscope prior to starting the procedure
Intervention Type
Device
Intervention Name(s)
AmplifEYE
Other Intervention Name(s)
colonoscope accessory device
Intervention Description
AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.
Primary Outcome Measure Information:
Title
Difference in adenoma detection rate (ADR), with and without use of AmplifEYE.
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
ADR will be differentiated according to morphology
Description
ADR will be differentiated according to morphology (flat, sessile, pedunculated)
Time Frame
1 week
Title
ADR will be differentiated according to final pathology
Description
ADR will be differentiated according to final pathology (sessile serrated adenomas, traditional serrated polyps, tubular/villous adenomas)
Time Frame
1 week
Title
ADR will be differentiated according to location
Description
Location will be specified by colon segment and flexures.
Time Frame
1 week
Title
Advanced ADR
Description
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
Time Frame
1 week
Title
Mean total number of polyps detected
Description
calculated by dividing the total number of adenomas detected by the total number of screening procedures performed
Time Frame
1 week
Title
ADR-plus
Description
mean number of adenomas found after the first in procedures in which 1 or more adenomas were detected
Time Frame
1 week
Title
APP (adenomas per positive participant)
Description
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)
Time Frame
1 week
Title
APC (adenomas per colonoscopy)
Description
calculated as the total number of adenomas detected during the first colonoscopy divided by the number of first colonoscopies
Time Frame
1 week
Title
Quality metrics: time of colonoscopy
Description
Differences in quality metrics will be noted: cecal intubation time and total withdrawal time.
Time Frame
1 hour
Title
Quality metrics: prep quality
Description
Differences in prep quality will be noted
Time Frame
1 hour
Title
Sedative Medications used
Description
Differences in sedative medications used
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Jahng, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate
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