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Validation Study of an Assistive Pulse Data Collection Device

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Trial completed Show 7 more changesShow less
    • Final enrollment: 45 participants (planned 30)
    • Start date: Mar 20, 2025 to Mar 1, 2025
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 15 words
    • Site details revised
    • Collaborators: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Traditional Chinese Medicine (TCM) relies on pulse diagnosis, a subjective and complex method that is crucial for assessing patients' health status. The COVID-19 pandemic has disrupted healthcare delivery, highlighting the need for remote diagnostic tools. To address this, an Assistive Pulse Data Collection Device (APDC) has been developed to capture and regenerate pulse features for remote pulse assessment in TCM. Objective: This study aims to validate the accuracy and reliability of the APDC by assessing its agreement with Chinese Medicine Practitioners (CMPs) and collecting users' feedback. Intervention: The APDC consists of a radial artery viewing device, pulse collection device, and pulse regeneration device. Methods: Subjects will be recruited via social media and posters at the University. Inclusion criteria include age 18-65 years and BMI 18.5-22.5 kg/m2, while exclusion criteria include a dorsally located radial artery. Registered CMPs with at least 5 years of clinical experience will assess the pulse from both participants and the regenerated pulse by the device. Outcome Assessment: Agreement in pulse features between the subjects' real pulse and the pulse regeneration device will be assessed using a self-developed questionnaire, covering frequency, rhythm, wideness, and force. Quantitative and qualitative feedback from subjects and CMPs will be collected to assess their views on the APDC Device in terms of satisfaction, ease of use, and comfortability.
Trial Details
NCT Number NCT06974227
Lead Sponsor The Hong Kong Polytechnic University
Collaborators: Logistics and Supply Chain MultiTech R&D Centre, Hong Kong
Conditions
(from sponsor)		 Healthy Male and Female Subjects
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov