Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

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?

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Ruby ROSE evaluation

Diagnostic Test

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

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

Sponsors and collaborators

Lead sponsor

Ruby Robotics Inc

Industry

Collaborators

Beth Israel Deaconess Medical Center

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 12, 2024
Registry last updated: Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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