Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis
Public ClinicalTrials.gov record NCT05147389. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Validation of an Artificial Intelligence Software for Digital Cholangioscopy Diagnosis: an Observational Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artificial intelligence (AI) tools is almost exclusively for intrahepatic CCA (iCCA). Therefore, more AI tools are necessary for assessing extrahepatic neoplastic bile duct lesions. In Ecuador, the investigators have recently proposed an AI model to classify bile duct lesions during real-time DSOC, which accurately detected malignancy patterns. This research pursues a clinical validation of our AI model for distinguishing between neoplastic and non-neoplastic bile duct lesions, compared with high DSOC experienced endoscopists.
Study identification
- NCT ID
- NCT05147389
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 170 participants
Conditions and interventions
Interventions
- AI model classification Diagnostic Test
- DSOC endoscopist experts' classification Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2020
- Primary completion
- Nov 29, 2021
- Completion
- Apr 30, 2022
- Last update posted
- Nov 16, 2022
2020 – 2022
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University | New Brunswick | New Jersey | 08901 | — |
| Baylor Saint Luke's Medical Center | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77098 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05147389, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 16, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05147389 live on ClinicalTrials.gov.