Adequacy Assessment of Bronchoscopic Biopsy Samples Using... | NCT06499454

Studies
Adequacy Assessment of Bronchoscopic Biopsy Samples Using a Novel Instrument

NCT06499454

Sponsor

Ruby Robotics Inc

Status

Not yet recruiting

Last Update Posted

Jul 12, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Lung Cancer
Lung Diseases

Interventions

Ruby ROSE evaluation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2024Estimated

Primary Completion Date

Nov 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Jul 5, 2024

First Submission Date that Met QC Criteria

Jul 5, 2024

First Posted Date

Jul 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2024

Last Update Posted Date

Jul 12, 2024Actual

Name	Class
Beth Israel Deaconess Medical Center	OTHER

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with suspected lung disease undergoing routine bronchoscopic biopsy			Diagnostic Test: Ruby ROSE evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ruby ROSE evaluation	Diagnostic 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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D008171	Lung Diseases

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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