Lung CancerNCT06499454
Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument
An observational study of Lung Cancer and Lung Diseases, run by Ruby Robotics Inc.
Trial summary
The goal of this study is to learn whether the Ruby Robotics system enables pathologists to determine whether a bronchoscopic biopsy sample is adequate for diagnosis. The main question it aims to answer is: Are pathologists' evaluations of Ruby digital images concordant with their evaluations of manually created rapid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Diseases
- What is being tested?
- Ruby ROSE evaluation
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will be selected from patients undergoing routine transbronchial lung and/or thoracic lymph node biopsy procedures
Who may be able to join
- The subject will undergo a planned, non-emergent transbronchial lung and/or thoracic lymph node biopsy.
Who cannot join
- -
About this study
The goal of this study is to learn whether the Ruby Robotics system enables pathologists to determine whether a bronchoscopic biopsy sample is adequate for diagnosis. The main question it aims to answer is:
- Are pathologists' evaluations of Ruby digital images concordant with their evaluations of manually created rapid on-site evaluation slides?
- Conditions
- Lung Cancer, Lung Diseases
- Being tested
- Ruby ROSE evaluation
- Keywords
- lung biopsy, bronchoscopy
- Medical subject headings
- Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruby ROSE evaluationDiagnostic test
Creation and digitization of ROSE slides produced using Ruby's instrument from bronchoscopic biopsy samples
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected lung disease undergoing routine bronchoscopic biopsy | Not described Receives: Diagnostic Test: Ruby ROSE evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides
Measured: 2 months from time of sample collection
Secondary outcomes (1)
Pathologist ratings of quality metrics for Ruby images and manually-prepared slides
Measured: 2 months from time of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruby Robotics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499454
- Sponsor's protocol ID
- RUBY2407
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument
- ClinicalTrials.gov ID
- NCT06499454
- Acronym / sponsor ID
- RUBY2407
- Conditions
- Lung Cancer, Lung Diseases
- Keywords
- lung biopsy, bronchoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruby Robotics IncIndustry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Jul 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 12 Jul 2024 (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.
The goal of this study is to learn whether the Ruby Robotics system enables pathologists to determine whether a bronchoscopic biopsy sample is adequate for diagnosis. The main question it aims to answer is:
- Are pathologists' evaluations of Ruby digital images concordant with their evaluations of manually created rapid on-site evaluation slides?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected lung disease undergoing routine bronchoscopic biopsy | – | Diagnostic Test: Ruby ROSE evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be selected from patients undergoing routine transbronchial lung and/or thoracic lymph node biopsy procedures
Key inclusion criteria (1 listed)
- The subject will undergo a planned, non-emergent transbronchial lung and/or thoracic lymph node biopsy.
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 |
|---|---|---|
| Ruby ROSE evaluationCreation and digitization of ROSE slides produced using Ruby's instrument from bronchoscopic biopsy samples | Diagnostic test | Patients with suspected lung disease undergoing routine bronchoscopic biopsy |
Primary outcome
Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides
Time frame: 2 months from time of sample collection
1 secondary outcome
Pathologist ratings of quality metrics for Ruby images and manually-prepared slides
Time frame: 2 months from time of sample collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Lung Diseases, run by Ruby Robotics Inc.
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 12 Jul 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides (time frame: 2 months 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 12 Jul 2024.