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8110 Gatehouse Road, Falls Church, VA 22042

Clinical Evaluation of ASP Health’s Automated ROSE System for Bronchoscopic Applications (ROSE)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

Inova U21-03-4417 ASP 031820

Background Information

Rapid On-Site Evaluation (ROSE) has dramatically improved patient care during Fine Needle Aspiration procedures by providing adequacy feedback. In the case of endobronchial ultrasound (EBUS) procedures, the samples that are collected from the patients are reviewed to determine adequacy of samples to ensure diagnostic quality. If the amount of specimen is found to be adequate, the interventional pulmonologists make additional passes to collect more specimen sample. While the existing ROSE method performed by smearing the samples on the glass slide and staining the slides has dramatically improved patient outcomes, it has several challenges/drawbacks. Some of the challenges of ROSE slide preparation include: (i) high variability in sample quality, (ii) cumbersome process in the procedure room and (iii) possibility of cross contamination between samples, (iv) slow specimen preparation and staining process which leads to extended procedure time and (v) the cost of the personnel to prepare slides.

The goal of this study is to conduct a trial of a novel automated sample preparation system that combines both the specimen deposition and staining in a compact/mobile unit. This automated system is expected to improve the workflow of the cytotechnologists and cytopathologists by ensuring reproducibility and efficiency. The early prototype of this instrument has been successfully tested at Cleveland Clinic on residual of EBUS samples, serous body fluids, and bench top FNAs with high diagnostic concordance.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Eligibility Information

  • Anyone who is undergoing EBUS procedure for diagnosis or staging of lung diseases
  • Additionaly eligibility in protocol
  • Adults 18 years of age or older

Ineligibility Information

  • N/A