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

NCT02856633 | Completed

• 1 other identifier: STP-VIT-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection; Diabetes Mellitus; Atrial Fibrillation; OSA; COPD; Pneumonia; Acute Otitis Media; Leukocytosis; Iron Deficient Anemia; Hypertension; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record

  90 minutes

Study Arms (1)

Vitaliti System

Device: Vitaliti

Interventions

Vitaliti DEVICE

Vitaliti System

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 to 65 years of age.
• English speaking
• Established diagnosis of one of the thirteen required conditions with evidence in Medical Record.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cloud DX Inc.: lead

Study Sites (1)

Oakville Trafalgar Memorial Hospital

Oakville, Ontario, L6M 0L8, Canada

Location

MeSH Terms

Conditions

Urinary Tract Infections; Diabetes Mellitus; Atrial Fibrillation; Pulmonary Disease, Chronic Obstructive; Pneumonia; Otitis Media; Leukocytosis; Hypertension

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases

Study Officials

• Sonny Kohli, MD

  Oakville Trafalgar Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 5, 2016
• Study Start: July 1, 2016
• Primary Completion: February 19, 2017
• Study Completion: May 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)