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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.

Tracking Information
First Submitted Date December 5, 2019
First Posted Date December 18, 2019
Last Update Posted Date December 18, 2019
Estimated Study Start Date March 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 16, 2019)
  • 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
  • Percentage of attempted studies with clinically useful images [ Time Frame: Up to 3 Months ]
    Compare the percentage of clinically useful versus not useful images
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of TTE Utilization in Medical Surgery Step-Down Unit
Official Title Evaluation of TTE Utilization in Medical Surgery Step-Down Unit: Use of AI Assisted Point-of-Care Echo With Guidance Technology
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients in the medical surgery step down unit at UCSF.
Condition Cardiac Disease
Intervention Device: Caption Health Guidance Technology
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 16, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Jade Andora, BS 831-521-3821 jade@captionhealth.com
Contact: Sara Cosenza, MA 301-512-8640 saracosenza@captionhealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04203251
Other Study ID Numbers CHUCSF01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Caption Health, Inc.
Study Sponsor Caption Health, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Caption Health, Inc.
Verification Date December 2019