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2024-01-19
2026-12
2027-12
310
NCT06564571
Orlando Health, Inc.
Orlando Health, Inc.
OBSERVATIONAL
Artificial Intelligence in Endoscopic Ultrasound
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-08-19 | N/A | 2025-05-27 |
2024-08-19 | N/A | 2025-05-31 |
2024-08-21 | N/A | 2024-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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. | DEVICE: Patients undergoing endoscopic ultrasound procedures
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of detection pancreatic solid mass lesions by AI | Ability of AI to detect pancreatic solid mass lesions as identified by an endoscopist during EUS examination of the pancreas. | 1 day |
| Rate of detection pancreatic cystic lesions by AI | Ability of AI to detect pancreatic cystic lesions as identified by an endoscopist during EUS examination of the pancreas. | 1 day |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Shyam Varadarajulu, MD Phone Number: 321-841-2431 Email: shyam.varadarajulu@orlandohealth.com |
Study Contact Backup Name: Barbara Broome Phone Number: 321-841-4356 Email: barbara.broome@orlandohealth.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
