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 (ColonCADe)

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

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.

Study Overview

• Status: Terminated
• Conditions: Colon Adenoma; Colon Polyp; Colon Neoplasm
• Intervention / Treatment: Device: EndoVigilant Software

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 769
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Pacific Gastroenterology Endoscopy Center
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Naugatuck Valley Surgical Center
  • Maryland
    • Greenbelt, Maryland, United States, 20706
      • Greenbelt Endoscopy Center
  • New Jersey
    • North Brunswick, New Jersey, United States, 08902
      • Dr. Satya Kastuar Gastroenterology Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is 45 years old or older.
2. 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).
3. Informed consent document for participating in the study signed by patient or patient's guardian.

Exclusion Criteria:

1. Patient has known history of inflammatory bowel disease (ulcerative colitis, Crohn's disease).
2. Patient has known or suspected polyposis or hereditary colon cancer syndrome (such as familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer).
3. 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).
4. Patient has history of colon resection (not including appendectomy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy Procedure with EndoVigilant Software; Colonoscopy Procedure is performed with EndoVigilant Software assisting the gastroenterologist during colonoscopy procedure.	Device: 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.
No Intervention: Colonoscopy Procedure without EndoVigilant Software; Colonoscopy Procedure is performed without EndoVigilant Software assisting the gastroenterologist during colonoscopy procedure.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: EndoVigilant Inc
• Investigators: Principal Investigator: Shai Friedland, MD, VA Palo Alto Health Care System

Publications and helpful links

General Publications

• Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
• Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
• Misawa M, Kudo SE, Mori Y, Cho T, Kataoka S, Yamauchi A, Ogawa Y, Maeda Y, Takeda K, Ichimasa K, Nakamura H, Yagawa Y, Toyoshima N, Ogata N, Kudo T, Hisayuki T, Hayashi T, Wakamura K, Baba T, Ishida F, Itoh H, Roth H, Oda M, Mori K. Artificial Intelligence-Assisted Polyp Detection for Colonoscopy: Initial Experience. Gastroenterology. 2018 Jun;154(8):2027-2029.e3. doi: 10.1053/j.gastro.2018.04.003. Epub 2018 Apr 11. No abstract available.
• Wang P, Berzin TM, Glissen Brown JR, Bharadwaj S, Becq A, Xiao X, Liu P, Li L, Song Y, Zhang D, Li Y, Xu G, Tu M, Liu X. Real-time automatic detection system increases colonoscopic polyp and adenoma detection rates: a prospective randomised controlled study. Gut. 2019 Oct;68(10):1813-1819. doi: 10.1136/gutjnl-2018-317500. Epub 2019 Feb 27.
• Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
• Klare P, Sander C, Prinzen M, Haller B, Nowack S, Abdelhafez M, Poszler A, Brown H, Wilhelm D, Schmid RM, von Delius S, Wittenberg T. Automated polyp detection in the colorectum: a prospective study (with videos). Gastrointest Endosc. 2019 Mar;89(3):576-582.e1. doi: 10.1016/j.gie.2018.09.042. Epub 2018 Oct 17.
• Singh S, Singh PP, Murad MH, Singh H, Samadder NJ. Prevalence, risk factors, and outcomes of interval colorectal cancers: a systematic review and meta-analysis. Am J Gastroenterol. 2014 Sep;109(9):1375-89. doi: 10.1038/ajg.2014.171. Epub 2014 Jun 24.
• Fernandez-Esparrach G, Bernal J, Lopez-Ceron M, Cordova H, Sanchez-Montes C, Rodriguez de Miguel C, Sanchez FJ. Exploring the clinical potential of an automatic colonic polyp detection method based on the creation of energy maps. Endoscopy. 2016 Sep;48(9):837-42. doi: 10.1055/s-0042-108434. Epub 2016 Jun 10.
• Wang P, Xiao X, Glissen Brown JR, Berzin TM, Tu M, Xiong F, Hu X, Liu P, Song Y, Zhang D, Yang X, Li L, He J, Yi X, Liu J, Liu X. Development and validation of a deep-learning algorithm for the detection of polyps during colonoscopy. Nat Biomed Eng. 2018 Oct;2(10):741-748. doi: 10.1038/s41551-018-0301-3. Epub 2018 Oct 10.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): September 24, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Colonoscopy; Artificial Intelligence; Computer Aided Detection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Intestinal Polyps; Adenoma; Polyps; Colonic Polyps; Colonic Neoplasms
• Other Study ID Numbers: EV-03-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: No