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Artificial Intelligence in Endoscopic Ultrasound

NCT06564571 — Recruiting, 310 participants, Orlando Health, Inc.

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RegistryNCT06564571
StatusRecruiting
Study typeObservational
Enrollment310 (Estimated)
SponsorOrlando Health, Inc. (Other)
ConditionsPancreatic Cancer, Pancreas Disease, Pancreatic Cyst
InterventionsPatients undergoing endoscopic ultrasound procedures (Device)
Datesstart 2024-01-19, primary completion 2026-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2024-08-21, last updated 2025-05-31
Locations1 site in United States

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-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.

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+Detailed description

Endoscopic Ultrasound (EUS) is an equipment where an ultrasound transducer is attached to the tip of the endoscope. When advanced to the stomach the organs outside such as the pancreas and liver can be visualized in great detail. This enables diagnosis of conditions such as pancreatic cancer. However, an endoscopist must undergo training to accurately interpret these ultrasound images.

The investigators are in the process of developing an artificial intelligence system that could potentially interpret EUS images. 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. Such correlation if established will lead to possible development of an artificial intelligence platform that can diagnose pancreatic diseases. Such development will potentially minimize human error and decrease learning curve to gain proficiency in EUS.

+Arms and interventions

ArmTypeInterventionsDescription
Patients undergoing endoscopic ultrasound proceduresDevice: Patients undergoing endoscopic ultrasound proceduresPatients 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.
  • Patients undergoing endoscopic ultrasound procedures (Device): 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.

+Outcome measures

Primary outcomes

  • Rate of detection pancreatic abnormalities by AI [1 day]: Ability of AI to detect pancreatic abnormalities as identified by an endoscopist during EUS examination of the pancreas.

Secondary outcomes

  • Rate of detection pancreatic solid mass lesions by AI [1 day]: Ability of AI to detect pancreatic solid mass lesions as identified by an endoscopist during EUS examination of the pancreas.
  • Rate of detection pancreatic cystic lesions by AI [1 day]: Ability of AI to detect pancreatic cystic lesions as identified by an endoscopist during EUS examination of the pancreas.

+Eligibility

Sex: All, ages: 18 Years to 100 Years

Inclusion Criteria:

* Age ≥ 18 years
* Any patient undergoing endoscopic ultrasound examination

Exclusion Criteria:

* Age < 18 years

+Locations (1)

FacilityCityCountryStatus
Orlando HealthOrlando, FloridaUnited StatesRecruiting

+Investigators

My Notes