Centro Hospitalar Universitário São João Porto, Porto, Portugal
Francisco Mendes, MD1, Miguel Mascarenhas Saraiva, MD, PhD1, João Ferreira, PhD2, João Afonso, MD1, William Sonnier, MD3, Bruno Rosa, MD4, Tiago Ribeiro, MD1, Tiago Cúrdia Gonçalves, MD4, Miguel Martins, MD1, Pedro Campelo, MD4, Claúdia Macedo, MD4, Pedro Cardoso, MD1, Joana Mota, MD1, Maria João Almeida, MD1, António Costa, MD5, Ana Peréz Gonzalez, MD5, Jorge Mendoza, MD6, Thiciane Cavalcante, MD7, Erika Fortes, MD8, Matheus Ferreira de Carvalho, MD9, Marcos Eduardo Lera dos Santos, MD9, Artur Kaffes, MD10, Robert Feller, MD11, Patrícia Andrade, MD1, Hélder Cardoso, MD1, Eduardo Hourneaux De Moura, MD, PhD12, Cecilio Santander, MD, PhD13, Benjamin Niland, MD14, Jack Di Palma, MD, MACG15, Jose Cotter, MD, PhD4, Guilherme Macedo, MD, PhD1 1Centro Hospitalar Universitário São João, Porto, Porto, Portugal; 2Faculdade de Engenharia da Universidade do Porto, Porto, Porto, Portugal; 3University of South Alabama College of Medicine, Mobile, AL; 4Hospital da Senhora da Oliveira, Guimarães, Braga, Portugal; 5Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Madrid, Spain; 6Hospital Universitario La Princesa, Pamplona, Navarra, Spain; 7Hospital Sírio-Libanês, São Paulo, Sao Paulo, Brazil; 8Albert Einstein Israelite Hospital, São Paulo, Sao Paulo, Brazil; 9Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, Sao Paulo, Brazil; 10Royal Prince Alfred Hospital, Sydney, New South Wales, Australia; 11St. Vincent's Hospital, Sydney, New South Wales, Australia; 12Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo, Sao Paulo, Brazil; 13Department of Gastroenterology, Hospital Universitario La Princesa, Madrid, Madrid, Spain; 14Division of Gastroenterology, University of South Alabama, Mobile, AL; 15USA Health, University of South Alabama, Mobile, AL Introduction: Capsule endoscopy (CE) is a key diagnostic tool for evaluating small bowel conditions, particularly Crohn’s disease. Detecting ulcers and erosions is essential for assessing disease activity, guiding treatment, and monitoring response. However, CE interpretation is time-consuming and prone to inter- reader variability. Artificial intelligence (AI), especially convolutional neural networks (CNNs), offers a promising solution by improving lesion detection, reducing variability, and shortening reading times. This study aimed to develop and validate an AI model for detecting and differentiating small bowel ulcers and erosions across multiple CE devices and clinical centers. Methods: A multicenter, prospective study was conducted between January 2021 and April 2025 across nine centers in Europe (Portugal and Spain), South America (Brazil), Australia, and the USA. Three CE systems (PillCam SB2, SB3 and Olympus EC-10) were used to perform 398 anonymized exams. AI-assisted readings generated by a deep learning model were compared with standard-of- care (SoC) readings, using expert board consensus as the gold standard. Diagnostic performance was assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUROC). Results: Ulcers and erosions were identified in 133 patients (33.4%) during expert review. SoC readings showed 68.9% sensitivity, 92.8% specificity, 82.7% PPV, 85.7% NPV, and 84.8% accuracy. AI-assisted readings achieved 87.9% sensitivity, 81.4% specificity, 70.3% PPV, 93.0% NPV, and 83.5% accuracy. The AI model detected 165 lesions versus 110 with SoC, performing consistently across CE platforms and centers. Mean AI-assisted reading time was 239 seconds (SD 138 seconds) per exam. Discussion: The AI model demonstrated higher sensitivity and reduced reading time compared to SoC. This is the first multicenter, interoperable validation of an AI tool for detecting and differentiating ulcers and erosions using data from multiple CE systems. These findings support AI integration as a reliable and efficient approach to enhance CE-based assessment in inflammatory bowel disease.
Figure: Figure 1 - Study Design and Main Findings.
Disclosures: Francisco Mendes indicated no relevant financial relationships. Miguel Mascarenhas Saraiva indicated no relevant financial relationships. João Ferreira indicated no relevant financial relationships. João Afonso indicated no relevant financial relationships. William Sonnier: Abbvie – Speakers Bureau. Eli Lily – Speakers Bureau. Bruno Rosa indicated no relevant financial relationships. Tiago Ribeiro indicated no relevant financial relationships. Tiago Cúrdia Gonçalves indicated no relevant financial relationships. Miguel Martins indicated no relevant financial relationships. Pedro Campelo indicated no relevant financial relationships. Claúdia Macedo indicated no relevant financial relationships. Pedro Cardoso indicated no relevant financial relationships. Joana Mota indicated no relevant financial relationships. Maria João Almeida indicated no relevant financial relationships. António Costa indicated no relevant financial relationships. Ana Peréz Gonzalez indicated no relevant financial relationships. Jorge Mendoza indicated no relevant financial relationships. Thiciane Cavalcante indicated no relevant financial relationships. Erika Fortes indicated no relevant financial relationships. Matheus Ferreira de Carvalho indicated no relevant financial relationships. Marcos Eduardo Lera dos Santos indicated no relevant financial relationships. Artur Kaffes indicated no relevant financial relationships. Robert Feller indicated no relevant financial relationships. Patrícia Andrade indicated no relevant financial relationships. Hélder Cardoso indicated no relevant financial relationships. Eduardo Hourneaux De Moura indicated no relevant financial relationships. Cecilio Santander indicated no relevant financial relationships. Benjamin Niland indicated no relevant financial relationships. Jack Di Palma indicated no relevant financial relationships. Jose Cotter indicated no relevant financial relationships. Guilherme Macedo indicated no relevant financial relationships.
Francisco Mendes, MD1, Miguel Mascarenhas Saraiva, MD, PhD1, João Ferreira, PhD2, João Afonso, MD1, William Sonnier, MD3, Bruno Rosa, MD4, Tiago Ribeiro, MD1, Tiago Cúrdia Gonçalves, MD4, Miguel Martins, MD1, Pedro Campelo, MD4, Claúdia Macedo, MD4, Pedro Cardoso, MD1, Joana Mota, MD1, Maria João Almeida, MD1, António Costa, MD5, Ana Peréz Gonzalez, MD5, Jorge Mendoza, MD6, Thiciane Cavalcante, MD7, Erika Fortes, MD8, Matheus Ferreira de Carvalho, MD9, Marcos Eduardo Lera dos Santos, MD9, Artur Kaffes, MD10, Robert Feller, MD11, Patrícia Andrade, MD1, Hélder Cardoso, MD1, Eduardo Hourneaux De Moura, MD, PhD12, Cecilio Santander, MD, PhD13, Benjamin Niland, MD14, Jack Di Palma, MD, MACG15, Jose Cotter, MD, PhD4, Guilherme Macedo, MD, PhD1. P4021 - Transforming IBD Diagnostics: A Multicenter Validation Study on Artificial Intelligence in Capsule Endoscopy, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.
