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NCT02856633 Clinical Trial

Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station

Hypertension Clinical Trial

Official title:
Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02856633
Other study ID # STP-VIT-001
Secondary ID
Status Completed
Phase N/A
First received July 29, 2016
Last updated May 8, 2017
Start date July 2016
Est. completion date May 2017

Study information
Verified date May 2017
Source Cloud DX Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital signs and to detect the health conditions required by the competition.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 2017
Est. primary completion date February 19, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age 18 to 65 years of age.

- English speaking

- Established diagnosis of one of the thirteen required conditions with evidence in Medical Record.

Exclusion Criteria:

- Lack of patient consent

- Has pacemaker or internal medical device

- Pregnancy

- Concurrent enrollment into a clinical trial that may affect subject treatment

- Age less than 18 or over 65

- Physical disabilities affecting vision (eyeglasses or contact lenses will be allowed), manual manipulation, or use of a computer or mobile device

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Vitaliti

Locations
Country Name City State
Canada Oakville Trafalgar Memorial Hospital Oakville Ontario

Sponsors (1)
Lead Sponsor Collaborator
Cloud DX Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record 90 minutes
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