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Evaluation of TTE Utilization in Medical Surgery Step-Down Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04203251
Recruitment Status : Not yet recruiting
First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Caption Health, Inc.

Brief 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.

Condition or disease Intervention/treatment
Cardiac Disease Device: Caption Health Guidance Technology

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of TTE Utilization in Medical Surgery Step-Down Unit: Use of AI Assisted Point-of-Care Echo With Guidance Technology
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020



Primary Outcome Measures :
  1. Mean time to acquire images [ Time Frame: Up to 3 months ]
    Assess the time to acquire cardiac ultrasound images with and without Caption AI Gudiance

  2. Percentage of attempted studies with clinically useful images [ Time Frame: Up to 3 Months ]
    Compare the percentage of clinically useful versus not useful images



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients in the medical surgery step down unit at UCSF.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203251


Contacts
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Contact: Jade Andora, BS 831-521-3821 jade@captionhealth.com
Contact: Sara Cosenza, MA 301-512-8640 saracosenza@captionhealth.com

Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Contact: Trevor Jensen, MD    415-476-7472    trevor.jensen@ucsf.edu   
Sponsors and Collaborators
Caption Health, Inc.
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Responsible Party: Caption Health, Inc.
ClinicalTrials.gov Identifier: NCT04203251    
Other Study ID Numbers: CHUCSF01
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Caption Health, Inc.:
Artificial Intelligence
Cardiac Monitoring
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases