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Colon PolypColonCADeNCT04555135

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

A study testing EndoVigilant Software in people with Colon Polyp and Colon Neoplasm, run by EndoVigilant Inc at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Colon Polyp, Colon Neoplasm, Colon Adenoma
What is being tested?
EndoVigilant Software
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
769 participants
Where
4 sitesUnited States
Study dates
28 Sep 2020to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Greenbelt Endoscopy Center

    Greenbelt, Maryland, 20706

  • Pacific Gastroenterology Endoscopy Center

    Mission Viejo, California, 92691

  • Dr. Satya Kastuar Gastroenterology Practice

    North Brunswick, New Jersey, 08902

  • Naugatuck Valley Surgical Center

    Waterbury, Connecticut, 06708

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
EndoVigilant Software
Keywords
Colonoscopy, Artificial Intelligence, Computer Aided Detection
Medical subject headings
Colonic Polyps, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoVigilant SoftwareDevice

    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.

Study groups in NCT04555135
Study groupRoleWhat they receive
Colonoscopy Procedure with EndoVigilant SoftwareExperimentalColonoscopy Procedure is performed with EndoVigilant Software assisting the gastroenterologist during colonoscopy procedure.
Receives: Device: EndoVigilant Software
Colonoscopy Procedure without EndoVigilant SoftwareNo interventionColonoscopy Procedure is performed without EndoVigilant Software assisting the gastroenterologist during colonoscopy procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  2. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

Secondary outcomes (11)

  1. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  2. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  3. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  4. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  5. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  6. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  7. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  8. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  9. 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.

    Measured: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)

  10. 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.

    Measured: Completion of the procedure (typically less than an hour)

  11. Procedure Time

    Average duration of the entire colonoscopy procedure for all study subjects undergoing colonoscopy procedures, separately calculated for each of the study arms.

    Measured: Completion of the procedure (typically less than an hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study start28 Sep 2020
  3. Primary completion24 Sep 2021
  4. Study completion30 Nov 2021

Why it stopped: Decision made based on Interim Analysis Results

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Random allocation stratified by gastroenterologist 50% randomized to colonoscopy procedure with device and 50% randomized to colonoscopy procedure without device
Masking
Single blind
Who is masked
Participant
Enrolment
769 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04555135
Sponsor's protocol ID
EV-03-0001
Acronym
ColonCADe
Status last verified
Mar 2022
First submitted
11 Sep 2020
Last updated
1 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22356322

  • 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.

    PubMed 30342029

  • 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.

    PubMed 24957158

  • 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.

    PubMed 30738046

  • 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.

    PubMed 27285900

  • 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.

    PubMed 29653147

  • 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.

    PubMed 29928897

  • 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.

    PubMed 31015647

  • 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.

    PubMed 30814121

  • Wei MT, Shankar U, Parvin R, Abbas SH, Chaudhary S, Friedlander Y, Friedland S. Evaluation of Computer-Aided Detection During Colonoscopy in the Community (AI-SEE): A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2023 Oct 1;118(10):1841-1847. doi: 10.14309/ajg.0000000000002239. Epub 2023 Mar 9.

    PubMed 36892545

Questions about this trial

What is this clinical trial studying?

A study testing EndoVigilant Software in people with Colon Polyp and Colon Neoplasm, run by EndoVigilant Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Decision made based on Interim Analysis Results). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Number of Adenomas Per Colonoscopy (time frame: Receipt of pathology results for procedure findings (typically within 2 weeks after the procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04555135, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

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