Home Monitoring Study for Surgical Patients

Обзор

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.

Вмешательства

• Устройство 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 pr

Первичные конечные точки

• Accuracy of Home-Based Vital Sign Monitoring Compared to Standard Clinical Measurements [Срок оценки: For a two-week period (twice daily) following their discharge from hospital.]

Вторичные конечные точки (1)

• Patient Compliance with Home Monitoring Protocol [Срок оценки: At one and two weeks post-hospital discharge]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• Mackenzie Health Science Centre — Edmonton

Идентификаторы

NCT: NCT07231653 · Pro00146230

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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