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NCT05018663 · ClinicalTrials.gov registry record
Artificial Intelligence (AI) Cytopathology Trial
A clinical trial of Pancreatic Solid Lesions, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT05018663: Recruiting study of Pancreatic Solid Lesions, sponsored by The University of Texas Health Science Center, Houston.
NCT05018663 is a study of Pancreatic Solid Lesions that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05018663, a study of Pancreatic Solid Lesions, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose The primary objective of the study is to compare interpretation of EUS FNA/FNB samples for adequacy between ROSE and AI at bedside. To compare accuracy of preliminary diagnosis results between ROSE and AI at bedside versus final pathology report. Research design This is a prospective single center study to compare performance characteristics in the interpretation of EUS FNA/FNB samples between AI and ROSE. Procedures to be used Eligible patients will undergo EUS guided FNA/FNA of PSLs using standard of care. Sample slides are prepared by a cytopathologist at bedside and observed under a microscope. At the same time, the slides are scanned using a slide scanner and those images are saved for interpretation by AI at a later time.
Primary Outcome
The primary outcome of the study is to determine how AI compares with ROSE in determining if EUS FNA/FNB sample from PSLs is adequate for diagnosis. This will be interpreted as a percentage in each group. The main study parameter is on-site determination if an EUS FNA/FNB sample is adequate for interpretation and diagnosis
Conditions Studied
Interventions
- OTHER Artificial Intelligence software ROSE
Study Locations (1)
Texas
- Memorial Hermann Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-07-21 |
| Est. Completion | 2028-01-30 |
What NCT05018663 shows while recruiting
NCT05018663 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 1 condition, with Pancreatic Solid Lesions appearing as the primary indexed condition, and to 1 intervention - of which Artificial Intelligence software ROSE is the first listed.
NCT05018663 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05018663 about?
NCT05018663 is a clinical study titled "Artificial Intelligence (AI) Cytopathology Trial". Purpose The primary objective of the study is to compare interpretation of EUS FNA/FNB samples for adequacy between ROSE and AI at bedside. To compare accuracy of preliminary diagnosis results between ROSE and AI at bedside versus final pathology report. Research design This is a prospective single...
What is the current status of trial NCT05018663?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2021-07-21. Estimated completion is 2028-01-30.
What conditions does trial NCT05018663 study?
This clinical trial studies the following conditions: Pancreatic Solid Lesions.
What interventions are being tested in trial NCT05018663?
The interventions under investigation include: Artificial Intelligence software ROSE (OTHER).
Who is sponsoring clinical trial NCT05018663?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05018663 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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