GI genius endoscopy module: a clinical profile

ABSTRACT

Introduction

The identification of early-stage colorectal cancers (CRC) and the resection of pre-cancerous neoplastic lesions through colonoscopy allows to decrease both CRC incidence and mortality. However, colonoscopy miss rates up to 26% for adenomas and 9% for advanced adenomas have been reported. In recent years, artificial intelligence (AI) systems have been emerging as easy-to-use tools, potentially lowering the risk of missing lesions.

Areas covered

This review paper focuses on GI Genius device (Medtronic Co. Minneapolis, MN, U.S.A.) a computer-assisted tool designed to assist endoscopists during standard white-light colonoscopies in detecting mucosal lesions.

Expert opinion

Randomized controlled trials (RCTs) suggest that GI Genius is a safe and effective tool for improving adenoma detection, especially in CRC screening and surveillance colonoscopies. However, its impact seems to be less significant among experienced endoscopists and in real-world clinical scenarios compared to the controlled conditions of RCTs. Furthermore, it appears that GI Genius mainly enhances the detection of non-advanced, small polyps, but does not significantly impact the identification of advanced and difficult-to-detect adenoma. When using GI Genius, no complications were documented. Only a small number of studies reported an increased in withdrawal time or the removal of non-neoplastic lesions.

KEYWORDS:

• Artificial intelligence
• colonoscopy
• colorectal cancer screening
• GI Genius
• adenoma detection rate

Article highlights

• Colorectal cancer (CRC) is the third most common tumor worldwide, arising from a slow stepwise process from pre-malignant lesions (i.e. adenomas and sessile-serrated lesions).

• Colonoscopy is the gold standard in CRC screening programs but missed lesions still represent an important issue, as demonstrated by post-colonoscopy CRC incidence.

• Artificial intelligent (AI) devices for polyp detection (CADe) represent promising tools to increase polyp detection during colonoscopy, making this procedure less operator-dependent and more standardized.

• GI Genius is AI-powered CADe device approved by the United States Food and Drugs Administrations for screening and surveillance colonoscopy. It is user-friendly, fully integrated within the endoscopic towers and compatible with all available endoscope brands.

• Video-based pre-clinical studies as well as real-life studies have widely tested the performance of GI Genius in various settings. While randomized controlled trials (RCTs) have consistently reported concrete benefits by the implementation of GI Genius, non-randomized clinical studies have shown conflicting results.

• The overall benefit of GI Genius is mainly due to a higher detection of small (<10 mm) polyps and seem to be higher among non-expert rather than expert endoscopists.

• GI Genius is a safe device and it has minimal impact over procedural time. False-positive activations, theoretically the main detrimental factor to its use, have marginal and negligible impact on clinical practice as reported in several studies.

• Further studies to evaluate the actual clinical impact as well as the long-standing benefit and the cost-effectiveness balance by the implementation of GI Genius are needed.

Abbreviations

Colorectal cancer (CRC), human development index (HDI), post-colonoscopy colorectal cancer (PCCRC), adenoma detection rate (ADR), fecal immunochemical test (FIT), artificial intelligence (AI), United States (US), computer-aided detection (CADe), computer-aided characterization (CADx), inflammatory bowel disease (IBD), true positive (TP), false positive (FP), per-polyp sensitivity (PPS), polyps per-colonoscopy (PPC), per-frame sensitivity (PFS), first detection time (FDT), randomized controlled trials (RCT), adenoma per colonoscopy (APC), sessile serrated lesions (SSLs), adenoma miss rate (AMR), polyp miss rate (PMR).

Declaration of interest

Radaelli Franco: Speaker honoraria from Fujifilm Co; research grant from Fujifilm Co; endoscopy equipment loan from Medtronic Co. Rondonotti Emanuele: speaker honoraria from Fujifilm Co., member of Fujifilm Co. expert group, Medtronic Co. consulting agreement. All the other authors declare no conflict of interest. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.