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

Colon Polyp Clinical Trial

— ColonCADe  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04555135
• Other study ID #: EV-03-0001
• Status: Terminated
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: EndoVigilant Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 769
• Est. completion date: November 30, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Neoplasm
• Colon Polyp
• Colonic Neoplasms
• Colonic Polyps
• Polyps

Intervention

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.

Locations

Country	Name	City	State
United States	Greenbelt Endoscopy Center	Greenbelt	Maryland
United States	Pacific Gastroenterology Endoscopy Center	Mission Viejo	California
United States	Dr. Satya Kastuar Gastroenterology Practice	North Brunswick	New Jersey
United States	Naugatuck Valley Surgical Center	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
EndoVigilant Inc

Country where clinical trial is conducted

United States, 

References & Publications (9)

Fernández-Esparrach G, Bernal J, López-Cerón M, Córdova H, Sánchez-Montes C, Rodríguez de Miguel C, Sánchez 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)