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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04203251
Other study ID # CHUCSF01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2020
Est. completion date May 2020

Study information

Verified date December 2019
Source Caption Health, Inc.
Contact Jade Andora, BS
Phone 831-521-3821
Email jade@captionhealth.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit. Patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: PLAX, PSAX-PM, AP4 and SubC4. Observations will be made regarding human factors and performance of the device.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 2020
Est. primary completion date May 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: .

- Patients =18 years old

- Patients in the medical surgery step-down clinical setting

- Patients who consent to participating in the study

Exclusion Criteria: .

- ? Patients with emergent or urgent episodes of injury and illness that can lead to death or disability without rapid intervention

- Unable to lie flat for study

- Patients experiencing a known or suspected acute cardiac event at the time of evaluation

- Patients with severe chest wall abnormalities

- Patients who have undergone pneumonectomy

- Patients with recent abdominal surgery

- Patients unwilling or unable to give written informed consent

- Principal Investigator determination to exclude the subject from participation

- Investigators also have the right to withdraw patient from the study in the event of illness, adverse events, or other reasons concerning the health or well-being of the patient, or in the case of non-compliance.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Caption Health Guidance Technology


Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Caption Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean time to acquire images Assess the time to acquire cardiac ultrasound images with and without Caption AI Gudiance Up to 3 months
Primary Percentage of attempted studies with clinically useful images Compare the percentage of clinically useful versus not useful images Up to 3 Months
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