Ainex Corporation (CEO David Lee) announced on the 12th that a clinical research paper utilizing its AI-powered diagnostic support software for gastrointestinal endoscopy, ENAD, has been published in the international gastroenterology journal Gut and Liver.

The study was conducted to evaluate the clinical effectiveness of AI-assisted colonoscopy (CADe) and was designed as a prospective, multicenter, randomized controlled trial.

According to the company, most previous multicenter studies on colonoscopy were limited by short study durations and relatively high baseline adenoma detection rates (ADR), making it difficult to reflect real-world clinical practice. To address these limitations, the present study was conducted over a two-year period from May 2023 to April 2025 at two leading tertiary hospitals in Korea: Korea University Medical Center and Ewha Womans University Medical Center.

A total of 998 patients were randomly assigned to either the CADe group using AI-assisted software (497 patients) or the control group (501 patients). The study compared the impact of AI-assisted software on adenoma detection rate (ADR), a key quality indicator in colonoscopy.

The results showed that the CADe group achieved higher rates in both ADR and polyp detection rate (PDR) compared to the control group. The PDR was approximately 17.7 percentage points higher, while the ADR increased by 16.2 percentage points in the CADe group.

The average number of polyps detected per colonoscopy was also significantly higher in the CADe group. While an average of 1.4 polyps per procedure was detected in the control group, the CADe group detected an average of 2.2 polyps. Similarly, the mean number of adenomas detected per colonoscopy was 1.2 in the CADe group, compared to 0.8 in the control group.

Notably, the AI system detected approximately 1.39 times more diminutive polyps (1–5 mm), which are typically more difficult to identify at an early stage. The study also demonstrated consistently higher detection rates across all segments of the colon. Furthermore, even after adjusting for variables such as sex, age, and examination time, the likelihood of detecting adenomas was approximately 1.9 times higher with the use of AI, the company added.

David Lee, CEO of Ainex, stated, “This multicenter clinical trial reconfirms the clinical value of ENAD. We will continue to conduct follow-up studies to validate the effectiveness of AI software across diverse patient populations and clinical settings.”