Urinary Tract InfectionNCT02856633
Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station
An observational study of Urinary Tract Infection and Diabetes Mellitus, run by Cloud DX Inc. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection, Diabetes Mellitus, Atrial Fibrillation
- What is being tested?
- Vitaliti
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18 to 65 years of age.
- English speaking
- Established diagnosis of one of the thirteen required conditions with evidence in Medical Record.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Vitaliti
- Medical subject headings
- Urinary Tract Infections, Diabetes Mellitus, Atrial Fibrillation, Pulmonary Disease, Chronic Obstructive, Pneumonia, Otitis Media, Leukocytosis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalitiDevice
| Study group | Role | What they receive |
|---|---|---|
| Vitaliti System | Not described Receives: Device: Vitaliti |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion19 Feb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cloud DX Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonny Kohli, MD, Principal investigator, Oakville Trafalgar Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856633
- Sponsor's protocol ID
- STP-VIT-001
- Status last verified
- May 2017
- First submitted
- 29 Jul 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station
- ClinicalTrials.gov ID
- NCT02856633
- Acronym / sponsor ID
- STP-VIT-001
- Conditions
- Urinary Tract Infection, Diabetes Mellitus, Atrial Fibrillation, OSA, COPD, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cloud DX Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- 19 Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitaliti System | – | Device: Vitaliti |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 to 65 years of age.
- English speaking
- Established diagnosis of one of the thirteen required conditions with evidence in Medical Record.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitaliti | Device | Vitaliti System |
Primary outcome
Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonny Kohli, MD principal investigator
Oakville Trafalgar Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection and Diabetes Mellitus, run by Cloud DX Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.