- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203251
Evaluation of TTE Utilization in Medical Surgery Step-Down Unit
December 16, 2019 updated by: Caption Health, Inc.
Evaluation of TTE Utilization in Medical Surgery Step-Down Unit: Use of AI Assisted Point-of-Care Echo With Guidance Technology
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jade Andora, BS
- Phone Number: 831-521-3821
- Email: jade@captionhealth.com
Study Contact Backup
- Name: Sara Cosenza, MA
- Phone Number: 301-512-8640
- Email: saracosenza@captionhealth.com
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California San Francisco
-
Contact:
- Trevor Jensen, MD
- Phone Number: 415-476-7472
- Email: trevor.jensen@ucsf.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients in the medical surgery step down unit at UCSF.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 3 months
|
Percentage of attempted studies with clinically useful images
Time Frame: Up to 3 Months
|
Compare the percentage of clinically useful versus not useful images
|
Up to 3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2020
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
December 5, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 18, 2019
Study Record Updates
Last Update Posted (Actual)
December 18, 2019
Last Update Submitted That Met QC Criteria
December 16, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUCSF01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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