Home Monitoring Study for Surgical Patients

Starting soon

Conditions studied: Patient Monitoring, Postoperative Period

In brief

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.

Key facts

Study ID

NCT07231653

Run by

University of Alberta

People needed

69

Starts

2026-06-01

Expected to finish

2027-12-31

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mackenzie Health Science Centre — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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