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

Completed

• Conditions: COPD; Urinary Tract Infection; Leukocytosis; Healthy Volunteers; Diabetes Mellitus; Atrial Fibrillation; Acute Otitis Media; Iron Deficient Anemia; Hypertension; OSA
• Interventions: Device: Vitaliti

• Registration Number: NCT02856633
• Lead Sponsor: Cloud DX Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Primary Completion: 2017-02-19
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitaliti System	Vitaliti	-

Primary Outcome Measures

Name	Time	Method
Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record	90 minutes

Trial Locations

Locations (1)

Oakville Trafalgar Memorial Hospital; 🇨🇦 Oakville, Ontario, Canada