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Trial Title: Artificial Inteligence in Endoscopic Ultrasound

NCT ID: NCT06564571

Condition: Pancreatic Cancer
Pancreas Disease
Pancreatic Cyst

Conditions: Official terms:
Pancreatic Neoplasms
Pancreatic Cyst
Pancreatic Diseases

Conditions: Keywords:
pancreatic disease
pancreatic cancer
pancreatic cyst
artificial intelligence

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Patients undergoing endoscopic ultrasound procedures
Description: 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.
Arm group label: Patients undergoing endoscopic ultrasound procedures

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.

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.

Criteria for eligibility:

Study pop:
Any patient 18 years or over undergoing endoscopic ultrasound examination

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Age ≥ 18 years - Any patient undergoing endoscopic ultrasound examination Exclusion Criteria: - Age < 18 years

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: Orlando Health

Address:
City: Orlando
Zip: 32806
Country: United States

Status: Recruiting

Contact:
Last name: Shyam Varadarajulu, MD

Phone: 321-841-2431
Email: shyam.varadarajulu@orlandohealth.com

Contact backup:
Last name: Barbara Broome

Phone: 321-841-4356
Email: barbara.broome@orlandohealth.com

Start date: January 19, 2024

Completion date: December 2027

Lead sponsor:
Agency: Orlando Health, Inc.
Agency class: Other

Source: Orlando Health, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06564571

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