TerminatedNot Applicable

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

Stopped: Decision made based on Interim Analysis Results

United States769 participantsStarted 2020-09-28

Plain-language 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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average Number of Adenomas Per Colonoscopy

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

Average Number of Adenomas Per Extraction

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

Trial details

NCT IDNCT04555135

SponsorEndoVigilant Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-24

View on ClinicalTrials.gov More Colon Polyp trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Average Number of Adenomas Per Colonoscopy

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

Average Number of Adenomas Per Extraction

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