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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Diseases; Lung Cancer
• Intervention / Treatment: Device: ASP Health instrument

Detailed Description

Rapid On-Site Evaluation (ROSE) has dramatically improved patient care during Fine Needle Aspiration procedures by providing adequacy feedback to the proceduralists. 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 samples are being processed. 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 from ASP Health 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.

ASP's sample preparation 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.

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Parvathi Viswanathan; Phone Number: 8474672867; Email: parvathi@nano-cytomics.com
• Study Contact Backup: Name: Hariharan Subramanian; Phone Number: 4252417385; Email: hariharan@nano-cytomics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort will be selected from patients visiting the pulmonology clinic for suspected lung lesions/diseases.

Description

Inclusion Criteria:

• Anyone who is undergoing EBUS procedure for diagnosis or staging of lung diseases.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with confirmed Lung cancer

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Evaluation of ASP Health's Instrument for Bronchoscopic Applications	Confirm that ASP Health's Instrument performance is not inferior to the standard of care procedures.	1 month from time of sample collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASP Health's Instrument compared to standard of care	ASP Health's Instrument has an improved clinical workflow compared to the standard of care procedures.	1 week from sample collection

Collaborators and Investigators

• Sponsor: ASP Health
• Collaborators: Mayo Clinic

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (ACTUAL): November 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Automated; Slide deposition; Slide stainer; Pahtology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: ASP_LT_004