The Food and Drug Administration (FDA) has granted 510(k) clearance to SKOUT™, a real-time computer-aided polyp detection device, to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
Using an AI-based algorithm, SKOUT is designed to highlight portions of the colon where the device detects potential colorectal polyps and provide real-time feedback; it does not increase total procedure or withdrawal time. The polyp detection notification, a 2-dimensional blue rectangular outline generated around any suspected polyps on the endoscopic video feed, enables users to detect potential colorectal polyps and utilize a tool that provides additional information for endoscopic observation. The bounding box automatically disappears when a medical tool enters the frame to avoid obstructing the physician’s view during polyp removal.
The FDA cleared the device based on data from a multicenter, randomized, controlled clinical study (ClinicalTrials.gov Identifier: NCT04754347) that evaluated its clinical benefit and safety for real-time polyp detection in colonoscopy procedures. The study included patients 40 years of age and older who were undergoing colonoscopy for screening or surveillance (at least 3 years), or undergoing a procedure by a participating endoscopist. Patients were randomly assigned to undergo standard colonoscopy with (n=682) or without (n=677) using SKOUT.
Findings showed that the overall detection of adenomas per colonoscopy (defined by the total number of adenomas detected divided by the total number of colonoscopies) statistically improved with SKOUT compared with standard colonoscopy (SKOUT vs standard: 1.05 vs 0.83, P =.002; total number of adenomas: 719 vs 562, respectively). In the proximal colon, findings showed a 44% relative increase in 5 to 9mm polyp detection when using SKOUT, and a 29% relative increase in 5 to 9mm polyp detection overall.
Moreover, there was no decrease in total histology rates with SKOUT compared with standard colonoscopy (Skout vs standard: 67.4% vs 71.7%, P for noninferiority <.001; total number of non-neoplastic lesions, 375 vs 284).
“Knowing that patients can walk away from their appointment with the confidence that they received a high quality and detailed colonoscopy is what excites us most about SKOUT’s FDA clearance,” said Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, and a primary investigator on the SKOUT registration study. “Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients.”
- Iterative Scopes receives FDA clearance for AI-assisted polyp detection device SKOUT™. News release. Iterative Scopes. Accessed September 23, 2022. https://www.businesswire.com/news/home/20220922005730/en/Iterative-Scopes-Receives-FDA-Clearance-for-AI-Assisted-Polyp-Detection-Device-SKOUT%E2%84%A2
- SKOUT 510(k) summary. Food and Drug Administration. Accessed September 26, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213686.pdf