NCT06499454

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?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 5, 2024

Last Update Submit

July 5, 2024

Conditions

Lung CancerLung Diseases

Keywords

lung biopsybronchoscopy

Outcome Measures

Primary Outcomes (1)

  • Concordance between pathologists' rapid evaluations of Ruby images and manually-prepared slides

    2 months from time of sample collection

Secondary Outcomes (1)

  • Pathologist ratings of quality metrics for Ruby images and manually-prepared slides

    2 months from time of sample collection

Study Arms (1)

Patients with suspected lung disease undergoing routine bronchoscopic biopsy

Diagnostic Test: Ruby ROSE evaluation

Interventions

Ruby ROSE evaluationDIAGNOSTIC_TEST

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

Patients with suspected lung disease undergoing routine bronchoscopic biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 12, 2024

Study Start

July 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07