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Computer-aided polyp detection multicenter international randomized controlled study with a focus on community clinics: Gastroenterology Artificial INtelligence system for detecting colorectal polyps - 16/07/26

Doi : 10.1016/j.gie.2025.12.290 
Cadman L. Leggett, MD 1, ⁎ , R. Scooter Plowman, MD, MBA, MHSA 2, 3, Lindsey Surace, MD 4, 5, Emmanuel Gorospe, MD, MPH 6, 7, Jesse Lachter, MD 8, Dana Ben-Ami Shor, MD 9, Keith Friedenberg, MD, MBA 10, David A. Leiman, MD, MSHP 11, Simon Schlachter, PhD 3, Anil Patwardhan, PhD 3, Roman Goldenberg, PhD 3, Ehud Rivlin, PhD 3, Leera Choi, BA 3, Nayantara Coelho-Prabhu, MD 1, Tonya Kaltenbach, MD 12, Michael Wallace, MD, MPH 13
1 Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA 
2 Stanford University Medical Center, Palo Alto, California, USA 
3 Verily Life Sciences, Dallas, Texas, USA 
4 Jackson-Siegelbaum Gastroenterology, Harrisburg, Pennsylvania, USA 
5 Janssen, Spring House, Pennsylvania, USA 
6 Paso del Norte Community Surgery Center, El-Paso, Texas, USA 
7 Castle Biosciences, Friendswood, Texas, USA 
8 Elisha Outpatient Endoscopy Center, Haifa, Israel 
9 Department of Gastroenterology, Tel-Aviv Sourasky Medical Center, affiliated to the Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel 
10 Endoscopy Center of Lake County, Mentor, Ohio, USA 
11 Duke University School of Medicine and Duke Clinical Research Institute, Durham, North Carolina, USA 
12 UCSF Division of Gastroenterology, Department of Medicine, San Francisco, California, USA 
13 Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA 

∗ Corresponding author: Cadman L. Leggett, MD, Department of Gastroenterology, Mayo Clinic, 200 1st St NW, Rochester, Minnesota 55905, USA. Department of Gastroenterology Mayo Clinic Rochester Minnesota 55905 USA

Abstract

Background and Aims

Computer-aided polyp detection (CADe) systems can enhance polyp detection, although their performance has largely been evaluated at academic rather than community practices. This randomized controlled trial evaluated the impact of the DEtection of Elusive Polyps-2 (DEEP 2 ) CADe system on colonoscopy quality metrics.

Methods

Participants undergoing routine colonoscopies were randomized to a control arm, standard-of-care high-definition white-light endoscopy (HD-WLE), or an intervention arm, HD-WLE with real-time DEEP 2 system assistance. Coprimary end points: adenomas per colonoscopy (APC; superiority evaluation at a 0.025 level of significance), and percent positive agreement (PPA, defined [per regulatory request] as the proportion of histologically confirmed clinically significant excised lesions relative to total lesions; noninferiority evaluation with a lower 95% CI threshold of −10%). Secondary end points included adenoma detection rate (ADR), polyp detection rate, polyps per colonoscopy, false positive rate, and false alarm rate.

Results

This study enrolled 1407 participants, most in community clinics ( n = 1208, 85.9%). Use of the DEEP 2 system resulted in significantly higher APC (0.74 vs 0.60; difference, 0.14; P = .0002). The PPA difference was −0.06 (95% CI, −0.15 to 0.03; P = .09). There was a numerical, but not statistically significant, ADR improvement (42.9% vs 38.9%; P = .031). A post hoc analysis revealed significant benefit in APC and ADR with the DEEP 2 system only within community clinics.

Conclusions

These results support the incorporation of CADe devices into colonoscopy practice for improving efficacy and quality over standard-of-care, particularly in community practices.

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : ADR, AI, APC, CADe, DEEP 2 , FAR, FPR, GAIN, HD-WLE, ITT, LS, mITT, MWT, PDR, PPA, PPC


Mappa


 Clinicaltrials.gov identifier: NCT05275556. Study registered: February 25, 2022; study started: March 1, 2022; enrolment: March 1, 2022 to October 26, 2023.


© 2026  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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