Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

Not yet recruiting

• Conditions: Lung Cancer; Lung Diseases
• Interventions: Diagnostic Test: Ruby ROSE evaluation

• Registration Number: NCT06499454
• Lead Sponsor: Ruby Robotics Inc

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspected lung disease undergoing routine bronchoscopic biopsy	Ruby ROSE evaluation	-

Primary Outcome Measures

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

Secondary Outcome Measures

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