Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

July 5, 2024 updated by: Ruby Robotics Inc

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The cohort will be selected from patients undergoing routine transbronchial lung and/or thoracic lymph node biopsy procedures

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected lung disease undergoing routine bronchoscopic biopsy
Diagnostic test: Ruby ROSE evaluation
Creation and digitization of ROSE slides produced using Ruby's instrument from bronchoscopic biopsy samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides
Time Frame: 2 months from time of sample collection
2 months from time of sample collection

Secondary Outcome Measures

Outcome Measure
Time Frame
Pathologist ratings of quality metrics for Ruby images and manually-prepared slides
Time Frame: 2 months from time of sample collection
2 months from time of sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruby Robotics Inc

Collaborators

Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUBY2407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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