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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05594940
Other study ID # BN03
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 21, 2022
Est. completion date February 23, 2024

Study information

Verified date February 2024
Source Butterfly Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to evaluate the feasibility of a novel app to facilitate heart failure patients to acquire lung ultrasound images and evaluate the quality of those images to expert scans, and to evaluate for relationships between the ultrasound data and pulmonary pressure data from the Abbott CardioMEMS system.


Description:

Feasibility study to compare an investigational Artificial Intelligence (AI) Auto B-line tool measurement on Lung Ultrasound (US) images acquired with an AI assisted guidance tool by novice ultrasound clinicians and heart failure (HF) patients, to standard of care heart failure monitoring of pulmonary artery pressure measured by the Abbott CardioMEMS system.


Recruitment information / eligibility

Status Terminated
Enrollment 22
Est. completion date February 23, 2024
Est. primary completion date February 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Documented diagnosis of heart failure at least three months prior to the date of consent 2. HF currently managed with the Abbott CardioMEMS device 3. Able to read and write in English. 4. At least 18 years of age or older on the date of consent. 5. Willing and able to provide written consent to participation 6. Expressed willingness to capture AI assisted US recordings immediately before or after taking their CardioMEMS measurements 7. Access to WiFi or cellular data connection at home 8. In the opinion of the investigator or delegate the subject, must be capable of complying with study procedures. Exclusion Criteria: 1. Previous experience using an ultrasound device on themselves or others 2. Women who are pregnant or plan to become pregnant during the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States John Muir Health Hospital, Concord Medical Center Concord California
United States John Muir Health Hospital, Walnut Creet Medical Center Walnut Creek California

Sponsors (1)

Lead Sponsor Collaborator
Butterfly Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patients Image Quality Image quality comparisons between ultrasound scans performed by heart failure patients using the study app to traditional ultrasound scans performed by trained clinicians Study Completion (91 days)
Primary Novice Image Quality Image quality comparisons between ultrasound scans performed by novice clinicians using the study app to traditional ultrasound scans performed by trained clinicians Study Completion (91 days)
Primary B-Line count CardioMEMS comparison Relationship comparisons between ultrasound data from exams performed by heart failure patients using the study app (both in clinic and at home) and ultrasound exams performed by novice clinicians to pulmonary pressure data from the Abbott CardioMEMS system Study Completion (91 days)
Secondary Ease of use Patient and novice clinician reported ease of use and satisfaction based on responses to user surveys. Study Completion (91 days)
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