Artificial Intelligence in Endoscopic Ultrasound
1 other identifier
observational
310
1 country
1
Brief Summary
The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2024
CompletedFirst Submitted
Initial submission to the registry
August 19, 2024
CompletedFirst Posted
Study publicly available on registry
August 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 31, 2025
August 1, 2024
2.9 years
August 19, 2024
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of detection pancreatic abnormalities by AI
Ability of AI to detect pancreatic abnormalities as identified by an endoscopist during EUS examination of the pancreas.
1 day
Secondary Outcomes (2)
Rate of detection pancreatic solid mass lesions by AI
1 day
Rate of detection pancreatic cystic lesions by AI
1 day
Study Arms (1)
Patients undergoing endoscopic ultrasound procedures
Patients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform.
Interventions
Patients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform.
Eligibility Criteria
Any patient 18 years or over undergoing endoscopic ultrasound examination
You may qualify if:
- Age ≥ 18 years
- Any patient undergoing endoscopic ultrasound examination
You may not qualify if:
- Age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orlando Health
Orlando, Florida, 32806, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shyam Varadarajulu, MD
Orlando Health, Digestive Health Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2024
First Posted
August 21, 2024
Study Start
January 19, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
May 31, 2025
Record last verified: 2024-08