Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

N/ANot Yet RecruitingNCT06499454

Ruby Robotics Inc50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lung Cancer Lung Diseases

Interventions

Ruby ROSE evaluationDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides

Time frame: 2 months from time of sample collection

Secondary Outcomes

Pathologist ratings of quality metrics for Ruby images and manually-prepared slides

Time frame: 2 months from time of sample collection

Data from ClinicalTrials.gov

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