Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

Ruby Robotics Inc

Status: Not yet enrolling

Conditions: Lung Diseases; Lung Cancer

Treatments: Diagnostic Test: Ruby ROSE evaluation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06499454

RUBY2407

Details and patient eligibility

About

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?

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

50 participants in 1 patient group

Patients with suspected lung disease undergoing routine bronchoscopic biopsy

Treatment:

Diagnostic Test: Ruby ROSE evaluation