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Clinical Evaluation of ASP Health's Automated ROSE System for Bronchoscopic Applications

NCT05120050 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-11-15

No results posted yet for this study

Summary

Prospective comparison of cytology slides (bronchoscopically derived fine needle aspiration samples of lymph nodes at the time of rapid intraprocedural on site evaluation) created with the ASP Health's specimen preparation system to slides made by existing conventional methods.

Conditions

Interventions

DEVICE

ASP Health instrument

The instrument is an integrated device with a short processing time (measured in 2 to 3 minutes) that distributes cells from limited volume samples (measured in microliters). The process involves a novel aerosolization technique that transfers liquid sample to a glass slide via a burst of air. After the sample is deposited on the glass slide, the automated system uses an integrated heating strip to heat the specimen slide. This process is similar to using a hair dryer to dry the specimen slide in the current ROSE setting. After drying the slide, the system uses series of pumps to dispense microliters of stain reagent onto the slide to stain the cells. Currently, the system is configured to perform DiffQuik staining, which is commonly used in the ROSE process. In the future, the staining capability will be broadened to include other staining processes such as Rapid PAP, H\&E staining etc.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • ASP Health

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05120050 on ClinicalTrials.gov