Home Monitoring Study for Surgical Patients

NCT07231653 | Not Yet Recruiting

• 1 other identifier: Pro00146230
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Patient Monitoring; Postoperative Period

Keywords

Wellvii VitalDetect; Remote patient monitoring; Postoperative monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  For a two-week period (twice daily) following their discharge from hospital.

Secondary Outcomes (1)

• Patient Compliance with Home Monitoring Protocol

  At one and two weeks post-hospital discharge

Other Outcomes (1)

• Patient satisfaction with Home Monitoring Protocol

  At the one-week and two-week clinic visits

Study Arms (1)

Home Monitoring - Surgical Patients

Device: Home-based Vital Sign Monitoring

Interventions

Home-based Vital Sign Monitoring DEVICE

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.

Home Monitoring - Surgical Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgical procedures, including day surgery procedures and those procedures requiring a hospital stay

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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Mackenzie Health Science Centre

Edmonton, Alberta, T6G 2B7, Canada

Location

Study Officials

• Todd McMullen, MD

  Mackenzie Health Science Centre, University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Archundia-Herrera, PhD

CONTACT

(587) 982-6635; archundi@ualberta.ca

Todd McMullen, MD

CONTACT

(780) 407-1108; tpm1@ualberta.ca

Study Design

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

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 17, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)