First AI device for colonoscopy: Extra set of expert ‘eyes’


The first artificial intelligence (AI) endoscopy module developed specifically to help detect adenomas during routine colonoscopy is making its debut following approval by the Food and Drug Administration on April 9.

The GI Genius module is the first and only commercially available computer-aided detection system that uses AI to identify colorectal polyps during routine colonoscopy.

The technology is compatible with most standard video endoscopy systems and has been “trained” to identify colonic lesions that are possibly cancerous, according to Medtronic, the distributor of the device.

“I think that anything we can do within a reasonable cost that enhances quality and patient outcomes during colonoscopy warrants very close consideration,” David Johnson, MD, professor of medicine and chief of gastroenterology, Eastern Virginia Medical School, Norfolk, said in an interview.

He was not involved with the development of the GI Genius system but has worked with a similar AI device that is used in conjunction with colonoscopy.

“The whole development of the technology for AI is done by inputting repetitive images into the computer, where it develops what is called the ‘neural network,’ ” he explained.

The computer then draws upon the “education” of this neural network to identify different types of colonic lesions, “and the more inputs that are put into the computer to enhance the neural network, the more capable the program becomes in the identification of variants and lesion size and characteristics,” Dr. Johnson added.

During routine colonoscopy, the GI Genius system generates visual markers – essentially, small green squares – and a low-volume sound whenever the software detects a region of interest.

These squares are superimposed on the video generated by the endoscope camera to alert the colonoscopist to regions that may require closer assessment, either visually, by tissue sampling, or by removal of the lesion itself.

“Colonoscopy is a durable screening and surveillance strategy, but it’s not perfect [because] it depends on a physician’s skill and their ability to pick up polyps in the colon,” Jeremy Glissen Brown, MD, of Beth Israel Deaconess Medical Center, Boston, said in an interview. He has also worked with an AI device.

Studies of adenoma detection during “all-comer” colonoscopies show that the rate of missed lesions ranges from a low of 6% to 40%, “so polyps are still missed during colonoscopy, and any technology that can solve parts of that problem is welcome,” Dr. Glissen Brown commented.

Clinical trial data that led to approval

The recent FDA approval of the GI Genius device was based on a prospective, randomized trial that was published in Gastroenterology in 2020. That trial involved 700 patients who were being screened or followed with colonoscopy every 3 years or longer. Participants underwent either white-light standard colonoscopy with the assistance of the GI Genius technology or standard white-light colonoscopy alone.

Results showed that the combination of standard colonoscopy and the GI Genius module identified laboratory-confirmed adenomas or carcinomas in 54.8% of patients, compared with 40.4% of patients who underwent colonoscopy alone.

In the Gastroenterology article, the authors wrote that the “14% absolute increase in adenoma detection rate obtained by computer-aided detection (CADe) in our study indicates that failure in polyp recognition is a clinically relevant cause of miss rate. Of note, the efficacy of CADe in reversing such miss rate also indicates that the same operator who missed the lesion in the first place was able to correctly diagnose it when the lesion was presented by the CADe. This underlines that the main cognitive challenge in polyp recognition is the discrimination between the candidate lesion and the surrounding healthy mucosa, whereas its correct characterization as neoplastic tissue that occurs after CADe detection is apparently a much easier task.”

The authors also noted that they did “not assess the actual number of false-positive activations by the system, as this would have altered the routine setting of our study,” but they refer to a study published in Gut in 2020 in which false-positive frames were seen in fewer than 1% of frames from the whole colonoscopy.

Because the new device improves on the ability of colonoscopy to detect lesions overall, it may reduce the risk of interval cancers between colonoscopies, Medtronic suggests.

Previous research has shown that every 1% increase in the adenoma detection rate results in a 3% decrease in the risk for colorectal cancer.

“More than 19 million screening colonoscopies are performed in the United State each year. ... Detection of adenomas during colonoscopy is an important quality metric,” James Weber, MD, a gastroenterologist affiliated with Texas Digestive Disease Consultants, Southlake, commented in a Medtronic press release.

“The addition of AI can increase the quality of colonoscopies, potentially improving diagnosis and outcomes for colon cancer patients,” he added.

Dr. Weber is also the CEO of GI Alliance, a physician-led national health care platform of independent GI practices in six states in the United States.


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