Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06499454

Enrollment

Registered

2024-07-12

Start date

2024-07-31

Completion date

2024-11-30

Last updated

2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Lung Diseases

Keywords

lung biopsy, bronchoscopy

Brief 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 on-site evaluation slides?

Interventions

DIAGNOSTIC_TESTRuby ROSE evaluation

Creation and digitization of ROSE slides produced using Ruby's instrument from bronchoscopic biopsy samples

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The subject will undergo a planned, non-emergent transbronchial lung and/or thoracic lymph node biopsy.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides	2 months from time of sample collection

Secondary

Measure	Time frame
Pathologist ratings of quality metrics for Ruby images and manually-prepared slides	2 months from time of sample collection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026