A Clinical Study To Measure The Effect Of Use Of Artificial Intelligence (AI) Enabled Computer Aided Detection (CADe) Assistance Software In Detecting Colon Polyps During Standard Colonoscopy Procedures

Study Overview
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Brief Summary
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EndoVigilant software device augments existing colonoscopy procedure video in real-time by highlighting colon polyps and mucosal abnormalities. It is intended to assist gastroenterologists in detection of adenomas and serrated polyps. The device is an adjunctive tool and is not intended to replace physicians' decision making related to detection, diagnosis or treatment. This study with an adaptive design measures the clinical benefit (increase in detection of adenomatous and serrated polyps) and increased risk (increased extraction of non-adenomas) during standard colonoscopy procedures when EndoVigilant software device is used.

Detailed Description
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This study will analyze the clinical benefit and risk of using the EndoVigilant polyp detection assistance software based device during screening and surveillance colonoscopy procedures. The study subjects will be randomized to a procedure with or without the use of EndoVigilant software. While using this device, colonoscopy will continue to be performed in the standard manner as is done without the use of this device. The video signal from the colonoscope will be fed into a computer running the EndoVigilant software in addition to the standard video output to the procedure monitor. The gastroenterologist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the augmented video on the second monitor. The gastroenterologist may rely on the second monitor (with augmented video generated from EndoVigilant software) for polyp detection, but the standard procedure monitor with the original feed will always be operational and available for maneuvers such as fast insertion, polypectomy etc. The study will have an adaptive design with an interim analysis after 700 subjects to re-estimate the final sample size of the study. The study will include a diverse set of endoscopists across age, sex, years of experience and practice settings. In order to comply with FDA guidance this pivotal study will only include endoscopists with ADR of 25-40% in their routine clinical practice. At the discretion of Endovigilant, endoscopists with an ADR of <25% or >40% may be included for a separate exploratory analysis to examine the impact of the system on endoscopists with ADR outside of the FDA-mandated range. But in accordance with FDA guidance, the procedures done by these endoscopists will not be included in the primary endpoint analysis.

Official Title
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A Prospective, Multi-Center, Randomized Controlled Clinical Study To Measure The Effect Of Use Of Artificial Intelligence (AI) Enabled Computer Aided Detection (CADe) Assistance Software In Detecting Colon Polyps During Standard Colonoscopy Procedures

Conditions
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Colon Polyp, Colon Neoplasm, Colon Adenoma

Intervention / Treatment
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* Device: EndoVigilant Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 45 years old or older. Patient is presenting for colon cancer screening or low-risk surveillance colonoscopy. Low risk surveillance is defined as the patient qualifying for a colonoscopy surveillance interval of 5 years based on US Multi-Society Task Force 2020 Guidelines (i.e., up to 4 tubular adenomas <1cm, up to 4 sessile serrated polyps <1cm on most recent colonoscopy). Informed consent document for participating in the study signed by patient or patient's guardian. Exclusion Criteria: Patient has known history of inflammatory bowel disease (ulcerative colitis, Crohn's disease). Patient has known or suspected polyposis or hereditary colon cancer syndrome (such as familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer). Patient referred for diagnostic colonoscopy to work up symptoms (such as abdominal pain or bleeding), laboratory abnormalities (such as anemia) or imaging findings (such as masses found on imaging). Patient has history of colon resection (not including appendectomy).

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random allocation stratified by gastroenterologist 50% randomized to colonoscopy procedure with device and 50% randomized to colonoscopy procedure without device
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonoscopy Procedure with EndoVigilant Software<br>Colonoscopy Procedure is performed with EndoVigilant Software assisting the gastroenterologist during colonoscopy procedure. | Device: EndoVigilant Software<br>* While using this device, colonoscopy will continue to be performed in the standard manner as is done without the use of this device. The video signal from the colonoscope will be fed into a computer running the EndoVigilant software in addition to the standard video output to the procedure monitor. The gastroenterologist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the augmented video on the second monitor. The gastroenterologist may rely on the second monitor (with augmented video generated from EndoVigilant software) for polyp detection, but the standard procedure monitor with the original feed will always be operational and available for maneuvers such as fast insertion, polypectomy etc.<br>|
| No Intervention: Colonoscopy Procedure without EndoVigilant Software<br>Colonoscopy Procedure is performed without EndoVigilant Software assisting the gastroenterologist during colonoscopy procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of Adenomas Per Colonoscopy | Average Number of Adenomas Per Colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Average Number of Adenomas Per Extraction | Percent of extractions that are adenomas per Colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of Serrated Polyps per Colonoscopy | Average Number of Serrated Polyps per Colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Average Number of Non-adenomatous, non-serrated polyps per colonoscopy | Average Number of Non-adenomatous, non-serrated polyps per colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Adenoma Detection Rate in Screening Colonoscopies | Adenoma Detection Rate in Screening Colonoscopies for study subjects undergoing screening colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Serrated Polyp Detection Rate in Screening Colonoscopies | Serrated Polyp Detection Rate in Screening Colonoscopies for study subjects undergoing screening colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Adenoma Detection Rate in All Colonoscopies | Adenoma Detection Rate in All Colonoscopies for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Serrated Polyp Detection Rate in All Colonoscopies | Serrated Polyp Detection Rate in All Colonoscopies for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Adenomatous Polyp Location Distribution Per Colonoscopy (Distal and Proximal Colon) | Adenomatous Polyp Location Distribution Per Colonoscopy (Distal and Proximal Colon) for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Adenomatous Polyp Size Distribution Per Colonoscopy <6mm, 6-10mm, or >=10mm) | Adenomatous Polyp Size Distribution Per Colonoscopy <6mm, 6-10mm, or >=10mm) for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Adenomatous Polyp Distribution by Paris Classification (Ip/Is, IIa/b/c) Per Colonoscopy | Adenomatous Polyp Distribution by Paris Classification (Ip/Is, IIa/b/c) Per Colonoscopy for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure) | 
| Withdrawal Time | Average time duration from the time when cecum is reached and the end of the colonoscopy procedure for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Completion of the procedure (typically less than an hour) | 
| Procedure Time | Average duration of the entire colonoscopy procedure for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms. | Completion of the procedure (typically less than an hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Artificial Intelligence, Computer Aided Detection