Back to resultsA Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Primary Purpose
Shortness of Breath
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caption LungAI
Sponsored by
About this trial
This is an interventional diagnostic trial for Shortness of Breath focused on measuring Lung Ultrasound, B-Lines, POCUS by non-expert user
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines. Exclusion Criteria: Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities
Sites / Locations
- Yale New Haven Hospital
- Northwestern University
- Rush University Medical CenterRecruiting
- The Moses H. Cone Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients presenting with clinical suspicion of B-Lines
Arm Description
Patients will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and will last approximately 5-10 minutes. The second exam will be conducted by a healthcare professional with Caption LungAI and will last approximately 15-20 minutes.
Outcomes
Primary Outcome Measures
Diagnostic Image Quality (Trained Healthcare Professional)
Evaluate the product's ability to assist the user to capture a LUS image with diagnostic quality. Percentage of zones with diagnostic image quality > 0.80
B-Lines Detection
Evaluate the product's ability to retrospectively detect present B-lines on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75
B-Line Significance
Evaluate the product's ability to retrospectively detect B-lines of significant severity on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75
Remote Reader Performance
Evaluate the product's impact on a remote expert reader's ability to interpret LUS images. Difference Between Aided &
Unaided Groups:
AUROC > 0.00; Sensitivity (Se) > 0.00; Specificity (Sp) > 0.00
Secondary Outcome Measures
Sub-group Analyses
The following sub-group analyses will be performed for the primary endpoints: age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, trained HCP, and zone of the image (1 - 8).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05992324
Brief Title
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Official Title
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Caption Health, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of Caption LungAI.
Detailed Description
After being informed about the study, all patients giving written informed consent will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and one exam conducted by a (non-expert) healthcare provider who is trained on Caption LungAI and will use Caption LungAI to capture images.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shortness of Breath
Keywords
Lung Ultrasound, B-Lines, POCUS by non-expert user
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients presenting with clinical suspicion of B-Lines
Arm Type
Experimental
Arm Description
Patients will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and will last approximately 5-10 minutes. The second exam will be conducted by a healthcare professional with Caption LungAI and will last approximately 15-20 minutes.
Intervention Type
Device
Intervention Name(s)
Caption LungAI
Intervention Description
Caption LungAI is a software that is designed to help non-expert healthcare professionals acquire diagnostic quality images on an 8-zone lung protocol for both healthy patients and patients presenting with pathology such as B-Lines.
Primary Outcome Measure Information:
Title
Diagnostic Image Quality (Trained Healthcare Professional)
Description
Evaluate the product's ability to assist the user to capture a LUS image with diagnostic quality. Percentage of zones with diagnostic image quality > 0.80
Time Frame
Up to 24 weeks from completion of the study.
Title
B-Lines Detection
Description
Evaluate the product's ability to retrospectively detect present B-lines on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75
Time Frame
Up to 24 weeks from completion of the study.
Title
B-Line Significance
Description
Evaluate the product's ability to retrospectively detect B-lines of significant severity on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75
Time Frame
Up to 24 weeks from completion of the study.
Title
Remote Reader Performance
Description
Evaluate the product's impact on a remote expert reader's ability to interpret LUS images. Difference Between Aided &
Unaided Groups:
AUROC > 0.00; Sensitivity (Se) > 0.00; Specificity (Sp) > 0.00
Time Frame
Up to 24 weeks from completion of the study.
Secondary Outcome Measure Information:
Title
Sub-group Analyses
Description
The following sub-group analyses will be performed for the primary endpoints: age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, trained HCP, and zone of the image (1 - 8).
Time Frame
Up to 24 weeks from completion of the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over the age of 18
Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines.
Exclusion Criteria:
Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roman Zingarelli
Phone
6145786384
Email
roman@captionhealth.com
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Denkewicz
Email
ryan.denkewicz@yale.edu
First Name & Middle Initial & Last Name & Degree
Chris Moore, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylwia Clarke
Phone
312-694-0802
Email
Sylwia.Clarke@nm.org
First Name & Middle Initial & Last Name & Degree
Baljash Cheema, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Manning
Phone
312-942-3470
Email
Pamela_Manning@rush.edu
First Name & Middle Initial & Last Name & Degree
Michael Gottlieb, MD
Facility Name
The Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Knapp
Email
Jennifer.Knapp@conehealth.com
First Name & Middle Initial & Last Name & Degree
Ravi Agarwala, MD
12. IPD Sharing Statement
Learn more about this trial
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
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