Artificial Intelligence in Endoscopic Ultrasound

NCT ID: NCT06564571

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-19

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer Pancreas Disease Pancreatic Cyst

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Patients undergoing endoscopic ultrasound procedures

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age \< 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlando Health, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyam Varadarajulu, MD

Role: PRINCIPAL_INVESTIGATOR

Orlando Health, Digestive Health Institute

Locations

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Orlando Health

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shyam Varadarajulu, MD

Role: CONTACT

321-841-2431

Barbara Broome

Role: CONTACT

321-841-4356

Facility Contacts

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Shyam Varadarajulu, MD

Role: primary

321-841-2431

Barbara Broome

Role: backup

321-841-4356

Other Identifiers

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24.015.01

Identifier Type: -

Identifier Source: org_study_id

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