Skip to content

Development and Multinational Validation in ASEAN Countries of DeepGI: An In-House Artificial Intelligence System for Real-Time Computer-aided diagnosis of Colonic Polyps with Emphasis on Diminutive Lesions

Development and Multinational Validation in ASEAN Countries of DeepGI: An In-House Artificial Intelligence System for Real-Time Computer-aided diagnosis of Colonic Polyps with Emphasis on Diminutive Lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20260724001
Enrollment
547
Registered
2026-07-24
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal polyps Diminutive colorectal polyps Colorectal neoplasms Colorectal cancer Artificial intelligence, Computer-aided diagnosis, Diminutive colorectal polyps, DeepGI

Interventions

Patients undergoing colonoscopy at participating study centers with at least one diminutive colorectal polyp measuring 5 mm or less. All eligible polyps will be evaluated in real time using the DeepGI
Diagnostic
Patients with diminutive colorectal polyps

Sponsors

Piyapoom Pakvisal
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Undergoing elective colonoscopy for colorectal cancer screening or surveillance 2. Adequate bowel preparation 3. At least one colorectal polyp detected during the procedure. 4. The polyp can be adequately visualized under both WLI and NBI. 5. The polyp is resected during the procedure and sent for histopathological examination. 6. Ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of inflammatory bowel disease or hereditary polyposis syndromes. 2. Failure of the AI system to generate a prediction with sufficient confidence. 3. Excessive colonic peristalsis that prevents the AI from producing stable or continuous outputs. 4. Polyp location in a concealed or poorly visualized area that precludes adequate assessment by the AI system. 5. Pseudopolyps 6. Subepithelial lesions 7. Colonic mass finding 8. Pregnant patients

Design outcomes

Primary

MeasureTime frame
Diagnostic performance At the index colonoscopy Diagnostic performance of DeepGI in distinguishing adenoma vs hyperplastic diminutive polyps using histopathology as reference standard under White light imaging (WLI) or naroow band imaging (NBI)

Secondary

MeasureTime frame
Performance comparison of WLI and NBI at Image interpretation to availability of the final histopathologic diagnosis Comparison of Diagnostic accuracy sensitivity specificity positive predictive value negative predictive value and area under receiver operating characteristic curve,Performance by polyp size and Paris morphology at Image interpretation to availability of the final histopathologic diagnosis Diagnostic accuracy sensitivity specificity positive predictive value negative predictive value and area under receiver operating characteristic curve by polyp size and Paris morphology,Performance in rectosigmoid area at Image interpretation to availability of the final histopathologic diagnosis Diagnostic accuracy sensitivity specificity positive predictive value negative predictive value and area under receiver operating characteristic curve in rectosigmoid colon,Performance across participation sites at Image interpretation to availability of the final histopathologic diagnosis Diagnostic accuracy sensitivity specificity positive predictive value negative predictive value and area under receiver operating characteristic curve across participating hospitals,Benchmark with Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) and Simple Optical Diagnosis Accuracy (SODA) criteria at Image interpretation to availability of the final histopathologic diagnosis Evaluate if diagnostic performance meet PIVI and SODA performance criteria or not

Countries

Thailand

Contacts

Public ContactPiyapoom Pakvisal

Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok

piyapoom_p@yahoo.com022564265

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026