Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
50 participants
OBSERVATIONAL
2021-07-21
2028-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.
NCT06718725
Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) With Rapid On-site Evaluation (ROSE) of Cytopathology vs. EUS-guided Fine Needle Biopsy (FNB) Alone in the Diagnosis of Pancreatic Solid Lesions
NCT03435588
EUS-FNB With MOSE vs EUS-FNA With ROSE
NCT03766659
EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses
NCT03485924
AI for Onsite Cytology Evaluation in Endoscopic Ultrasound
NCT07228689
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prospective enrollment
All subjects will be enrolled prospectively. Subjects will be included in the study after eligibility is assessed and informed consent is obtained. The slide scanner will scan the slides on site and the images will be securely saved and sent for interpretation by the AI software at a different location. The results of the AI interpretation of the slides will be blinded to the on-site procedure team including the endoscopist and cytopathologist until the final pathology report is complete.
Artificial Intelligence software ROSE
Rapid on-site evaluation (ROSE) of Endoscopic Ultrasound (EUS) guided FNA/FNB (Fine Needle Aspirate/Fine Needle Biopsy) of pancreatic solid lesions (PSLs) has been shown in improve diagnostic yield. The availability and performance of ROSE at EUS performing centers is variable. With strides in Artificial Intelligence (AI) capabilities over the years, the University of Texas at Health Sciences Center at Houston in collaboration with Haystac is developing an artificial intelligence based proprietary system to analyze slides from EUS FNA/FNB samples at bedside.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Artificial Intelligence software ROSE
Rapid on-site evaluation (ROSE) of Endoscopic Ultrasound (EUS) guided FNA/FNB (Fine Needle Aspirate/Fine Needle Biopsy) of pancreatic solid lesions (PSLs) has been shown in improve diagnostic yield. The availability and performance of ROSE at EUS performing centers is variable. With strides in Artificial Intelligence (AI) capabilities over the years, the University of Texas at Health Sciences Center at Houston in collaboration with Haystac is developing an artificial intelligence based proprietary system to analyze slides from EUS FNA/FNB samples at bedside.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Do not have contraindications for FNA/FNB.
Exclusion Criteria
* Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nirav C Thosani
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nirav Thosani, MD, MHA
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Memorial Hermann Hospital
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSC-MS-21-0051
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.