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

May 8, 2017 updated by: Cloud DX Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6M 0L8
        • Oakville Trafalgar Memorial Hospital

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult subjects with urinary tract infection, diabetes mellitus, atrial fibrillation, sleep apnea, COPD, pneumonia, acute otitis media, leukocytosis, anemia, or hypertension will be recruited to participate in this observational study from Oakville-Trafalgar Memorial Hospital.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vitaliti System
Device: Vitaliti

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record
Time Frame: 90 minutes
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cloud DX Inc.

Investigators

  • Principal Investigator: Sonny Kohli, MD, Oakville Trafalgar Memorial Hospital

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 (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

February 19, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (ESTIMATE)

August 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STP-VIT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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