Clinical trial · Observational

Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

NCT06499454CI-TRIAL-00078783unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Lung Diseases	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Ruby ROSE evaluation	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Patients with suspected lung disease undergoing routine bronchoscopic biopsy
interventionNames
1. Diagnostic Test: Ruby ROSE evaluation

Primary outcomes (1)

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

Secondary outcomes (1)

measure
Pathologist ratings of quality metrics for Ruby images and manually-prepared slides
timeFrame
2 months from time of sample collection

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

\-

References

Publications (0)

Data not yet available

No reference posted for this study.