Lung DiseasesNCT05120050
Clinical Evaluation of ASP Health's Automated ROSE System for Bronchoscopic Applications
An observational study of Lung Diseases and Lung Cancer, run by ASP Health.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Diseases, Lung Cancer
- What is being tested?
- ASP Health instrument
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cohort will be selected from patients visiting the pulmonology clinic for suspected lung lesions/diseases.
Who may be able to join
- Anyone who is undergoing EBUS procedure for diagnosis or staging of lung diseases.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Lung Diseases, Lung Cancer
- Being tested
- ASP Health instrument
- Keywords
- Slide deposition, Slide stainer, Automated, Pahtology
- Medical subject headings
- Lung Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP Health instrumentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed Lung cancer | Not described Receives: Device: ASP Health instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month from time of sample collection
Secondary outcomes (1)
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.
Measured: 1 week from sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASP Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120050
- Sponsor's protocol ID
- ASP_LT_004
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of ASP Health's Automated ROSE System for Bronchoscopic Applications
- ClinicalTrials.gov ID
- NCT05120050
- Acronym / sponsor ID
- ASP_LT_004
- Conditions
- Lung Diseases, Lung Cancer
- Keywords
- Slide deposition, Slide stainer, Automated, Pahtology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ASP HealthIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed Lung cancer | – | Device: ASP Health instrument |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort will be selected from patients visiting the pulmonology clinic for suspected lung lesions/diseases.
Key inclusion criteria (1 listed)
- Anyone who is undergoing EBUS procedure for diagnosis or staging of lung diseases.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP Health instrumentThe 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. | Device | Patients with confirmed Lung cancer |
Primary outcome
Clinical Evaluation of ASP Health's Instrument for Bronchoscopic Applications
Time frame: 1 month from time of sample collection
Confirm that ASP Health's Instrument performance is not inferior to the standard of care procedures.
1 secondary outcome
ASP Health's Instrument compared to standard of care
Time frame: 1 week from sample collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Lung Cancer, run by ASP Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Parvathi Viswanathan (8474672867, parvathi@nano-cytomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Evaluation of ASP Health's Instrument for Bronchoscopic Applications (time frame: 1 month from time of sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.