Home Monitoring Study for Surgical Patients

NCT ID: NCT07231653

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Home Monitoring - Surgical Patients

Home-based Vital Sign Monitoring

Intervention Type: 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.

Interventions

Home-based Vital Sign Monitoring

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd McMullen, MD

Role: PRINCIPAL_INVESTIGATOR

Mackenzie Health Science Centre, University of Alberta

Locations

Mackenzie Health Science Centre

Edmonton, Alberta, Canada

Countries

Canada

Central Contacts

Carolina Archundia-Herrera, PhD

Role: CONTACT

archundi@ualberta.ca

(587) 982-6635

Todd McMullen, MD

Role: CONTACT

tpm1@ualberta.ca

(780) 407-1108

Facility Contacts

Carolina Archundia-Herrera, PhD

Role: primary

archundi@ualberta.ca

(587) 982-6635

Todd McMullen, MD

Role: backup

tpm1@ualberta.ca

(780) 407-1108

Other Identifiers

Pro00146230

Identifier Type: -

Identifier Source: org_study_id