Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

NCT ID: NCT06499454

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2024-11-30

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?

Conditions

Lung Cancer; Lung Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with suspected lung disease undergoing routine bronchoscopic biopsy

Ruby ROSE evaluation

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Ruby ROSE evaluation

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Ruby Robotics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RUBY2407

Identifier Type: -

Identifier Source: org_study_id