Computer Aided Detection of Polyps During Colonoscopy Procedures
NCT ID: NCT04195646
Last Updated: 2021-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2019-10-01
2020-02-28
Brief Summary
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Detailed Description
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1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place. The video signal from the colonoscope will be fed into a computer running the EndoVigilant CAD software in addition to the standard video output to the procedure monitor. The EndoVigilant CAD software will display an annotated video on an additional monitor that includes both the colonoscopy picture and annotation by the software indicating the location of any polyps on the screen.
2. The endoscopist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the annotated video on the second monitor.
3. The endoscopist will primarily rely on the second monitor (augmented with annotation from EndoVigilant ColonCAD software) but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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EndoVigilant CAD Software assisted Colonoscopy Procedure
The gastroenterologist performing the colonoscopy procedure will be able to observe a standard colonoscopy video on the primary monitor and video augmented by EndoVigilant CAD software on the second monitor. The gastroenterologist will primarily rely on the second monitor but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.
EndoVigilant CAD Software
The CAD software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the CAD software is installed on a computer system unit that utilizes an an operating system.
Interventions
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EndoVigilant CAD Software
The CAD software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the CAD software is installed on a computer system unit that utilizes an an operating system.
Eligibility Criteria
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Inclusion Criteria
* Ability to provide written, informed consent and understand the responsibilities of study participation
Exclusion Criteria
* Patients with inflammatory bowel disease, ulcerative colitis or Crohn's colitis
* Patients with incomplete colonoscopies (due to technical difficulties or poor bowel prep)
18 Years
85 Years
ALL
Yes
Sponsors
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EndoVigilant Inc
INDUSTRY
Responsible Party
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Locations
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VA Palo Alto Healthcare
Palo Alto, California, United States
Greenbelt Endoscopy Center
Greenbelt, Maryland, United States
Countries
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Other Identifiers
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EV-CS-001
Identifier Type: -
Identifier Source: org_study_id
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