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

NCT05120050 | Unknown

• 1 other identifier: ASP_LT_004
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Lung Diseases; Lung Cancer

Keywords

Slide deposition; Slide stainer; Automated; Pahtology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ASP Health's Instrument compared to standard of care

  1 week from sample collection

Study Arms (1)

Patients with confirmed Lung cancer

Device: ASP Health instrument

Interventions

ASP Health instrument DEVICE

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.

Patients with confirmed Lung cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• ASP Health: lead
• Mayo Clinic: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cytological specimens

MeSH Terms

Conditions

Lung Diseases; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Parvathi Viswanathan

CONTACT

8474672867; parvathi@nano-cytomics.com

Hariharan Subramanian

CONTACT

4252417385; hariharan@nano-cytomics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 15, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 15, 2021

Record last verified: 2021-11