Home Monitoring Study for Surgical Patients

University of Alberta

Status: Not yet enrolling

Conditions: Patient Monitoring; Postoperative Period

Treatments: Device: Home-based Vital Sign Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT07231653

Pro00146230

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

69 participants in 1 patient group

Home Monitoring - Surgical Patients

Treatment:

Device: Home-based Vital Sign Monitoring