Patient MonitoringNCT07231653
Home Monitoring Study for Surgical Patients
An observational study of Patient Monitoring and Postoperative Period, run by University of Alberta at 1 site in Canada.
Trial summary
This clinical trial is designed to evaluate the accuracy, usability, and patient compliance of the Wellvii VitalDetect, an FDA-cleared (510(k) K231625), Class II medical device intended for non-invasive monitoring of vital signs including blood pressure, pulse rate, and temperature. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Monitoring, Postoperative Period
- What is being tested?
- Home-based Vital Sign Monitoring
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgical procedures, including day surgery procedures and those procedures requiring a hospital stay
Who may be able to join
- Clinically stable patients requiring routine postoperative monitoring in the absence of any acute illness following surgery.
- Able to use a smartphone or tablet for the monitoring system.
Who cannot join
- Severe cognitive impairment or conditions that may interfere with the use of home monitoring devices.
- Currently participation in other clinical trials involving vital sign monitoring.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Mackenzie Health Science Centre
Edmonton, Alberta, T6G 2B7
Carolina Archundia-Herrera, PhD, (587) 982-6635, archundi@ualberta.ca
Todd McMullen, MD, (780) 407-1108, tpm1@ualberta.ca
About this study
This clinical trial is designed to evaluate the accuracy, usability, and patient compliance of the Wellvii VitalDetect, an FDA-cleared (510(k) K231625), Class II medical device intended for non-invasive monitoring of vital signs including blood pressure, pulse rate, and temperature. The study will focus on comparing measurements obtained in a home environment using the device to those collected in a clinical setting, with the goal of validating the device's performance for real-world, at-home use.
The Wellvii VitalDetect is a portable, battery-operated, spot-check monitor that uses finger-based technology for most parameters and an infrared sensor for forehead-based, non-contact temperature readings. It is designed for use by adults (18 years or older) in a home environment and is not intended for continuous monitoring. In addition to the cleared vital signs, the device displays other wellness parameter for general health tracking. A smartphone application supports the user experience by delivering usage instructions and data display.
Read more
The study will assess:
- Measurement accuracy compared to standard clinical instruments
- Patient ease-of-use and engagement with the device
- Adherence to regular self-monitoring schedules
- Overall user satisfaction and confidence I home-based monitoring
This research will contribute to the growing body of evidence supporting remote patient monitoring solutions and aims to advance the adoption of decentralized technology-enabled healthcare delivery.
The study aligns with Wellvii Inc.'s mission to transform healthcare delivery by enabling continuous, connected health monitoring from the home. The ultimate goal is to empower patients and healthcare providers with real-time, clinically actionable health at a that can lead to earlier intervention, improved outcomes, and reduced system burden.
- Conditions
- Patient Monitoring, Postoperative Period
- Being tested
- Home-based Vital Sign Monitoring
- Keywords
- Wellvii VitalDetect, Remote patient monitoring, Postoperative monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Vital Sign MonitoringDevice
Postoperative surgical patient will use the Wellvii VitalDetect, an FDA-cleared, non-invasive, handheld device for home-based monitoring of blood pressure, pulse rate, and temperature. After receiving training at discharge and recording baseline vital signs in clinic, participants will monitor their vital signs twice daily for two weeks using the device and a companion mobile app. Weekly clinic visits will collect corroborating data. The device does not requires calibration or maintenance and provides results in under 90 seconds. Usability and satisfaction will be assessed through questionnaires, and compliance will be monitored via app logs. Data will be automatically uploaded to a secure, de-identified database for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Home Monitoring - Surgical Patients | Not described Receives: Device: Home-based Vital Sign Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Home-Based Vital Sign Monitoring Compared to Standard Clinical Measurements
This outcome measures the accuracy of vital sign readings (temperature, blood pressure, and heart rate) collected at home using the Wellvii VitalDetect™ compared to standard clinical equipment readings taken during weekly hospital visits. Accuracy will be evaluated using paired t-tests to compare mean differences between home and clinical measurements.
Measured: For a two-week period (twice daily) following their discharge from hospital.
Secondary outcomes (1)
Patient Compliance with Home Monitoring Protocol
This outcome assess participant compliance with the home monitoring protocol, defined as the percentage of days during the two-week study period in which complete vital sign measurements are successfully recorded using the device and app.
Measured: At one and two weeks post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient MonitoringStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd McMullen, MD, Principal investigator, Mackenzie Health Science Centre, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231653
- Sponsor's protocol ID
- Pro00146230
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Monitoring Study for Surgical Patients
- ClinicalTrials.gov ID
- NCT07231653
- Acronym / sponsor ID
- Pro00146230
- Conditions
- Patient Monitoring, Postoperative Period
- Keywords
- Wellvii VitalDetect, Remote patient monitoring, Postoperative monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- 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.
This clinical trial is designed to evaluate the accuracy, usability, and patient compliance of the Wellvii VitalDetect, an FDA-cleared (510(k) K231625), Class II medical device intended for non-invasive monitoring of vital signs including blood pressure, pulse rate, and temperature. The study will focus on comparing measurements obtained in a home environment using the device to those collected in a clinical setting, with the goal of validating the device's performance for real-world, at-home use.
The Wellvii VitalDetect is a portable, battery-operated, spot-check monitor that uses finger-based technology for most parameters and an infrared sensor for forehead-based, non-contact temperature readings. It is designed for use by adults (18 years or older) in a home environment and is not intended for continuous monitoring. In addition to the cleared vital signs, the device displays other wellness parameter for general health tracking. A smartphone application supports the user experience by delivering usage instructions and data display.
The study will assess:
- Measurement accuracy compared to standard clinical instruments
- Patient ease-of-use and engagement with the device
- Adherence to regular self-monitoring schedules
- Overall user satisfaction and confidence I home-based monitoring
This research will contribute to the growing body of evidence supporting remote patient monitoring solutions and aims to advance the adoption of decentralized technology-enabled healthcare delivery.
The study aligns with Wellvii Inc.'s mission to transform healthcare delivery by enabling continuous, connected health monitoring from the home. The ultimate goal is to empower patients and healthcare providers with real-time, clinically actionable health at a that can lead to earlier intervention, improved outcomes, and reduced system burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Monitoring - Surgical Patients | – | Device: Home-based Vital Sign Monitoring |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical procedures, including day surgery procedures and those procedures requiring a hospital stay
Key inclusion criteria (2 listed)
- Clinically stable patients requiring routine postoperative monitoring in the absence of any acute illness following surgery.
- Able to use a smartphone or tablet for the monitoring system.
Key exclusion criteria (3 listed)
- Severe cognitive impairment or conditions that may interfere with the use of home monitoring devices.
- Currently participation in other clinical trials involving vital sign monitoring.
- Unable to provide informed consent.
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 |
|---|---|---|
| Home-based Vital Sign MonitoringPostoperative surgical patient will use the Wellvii VitalDetect, an FDA-cleared, non-invasive, handheld device for home-based monitoring of blood pressure, pulse rate, and temperature. After receiving training at discharge and recording baseline vital signs in clinic, participants will monitor their vital signs twice daily for two weeks using the device and a companion mobile app. Weekly clinic visits will collect corroborating data. The device does not requires calibration or maintenance and provides results in under 90 seconds. Usability and satisfaction will be assessed through questionnaires, and compliance will be monitored via app logs. Data will be automatically uploaded to a secure, de-identified database for analysis. | Device | Home Monitoring - Surgical Patients |
Primary outcome
Accuracy of Home-Based Vital Sign Monitoring Compared to Standard Clinical Measurements
Time frame: For a two-week period (twice daily) following their discharge from hospital.
This outcome measures the accuracy of vital sign readings (temperature, blood pressure, and heart rate) collected at home using the Wellvii VitalDetect™ compared to standard clinical equipment readings taken during weekly hospital visits. Accuracy will be evaluated using paired t-tests to compare mean differences between home and clinical measurements.
1 secondary outcome
Patient Compliance with Home Monitoring Protocol
Time frame: At one and two weeks post-hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- 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.
Todd McMullen, MD principal investigator
Mackenzie Health Science Centre, University of Alberta
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 Patient Monitoring and Postoperative Period, run by University of Alberta 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Archundia-Herrera, PhD ((587) 982-6635, archundi@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Home-Based Vital Sign Monitoring Compared to Standard Clinical Measurements (time frame: For a two-week period (twice daily) following their discharge from hospital.). 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 17 Aug 2026.