Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation

Not Applicable

Active, not recruiting

• Conditions: Blood Pressure
• Interventions: Device: Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement

• Registration Number: NCT05735210
• Lead Sponsor: ChroniSense Medical Ltd.

Brief Summary

Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement.

Detailed Description

The purpose of this validation study is to assess, in an adult population, the three fundamental clinical tests:

1. Blood pressure measurement accuracy ("accuracy test")

2. Measurement accuracy after blood pressure change ("change test")

3. Blood pressure measurement accuracy throughout the specified stability-period ("stability test") To provide evidence that the device can track changes in blood pressure, this study includes study conditions that specifically induce changes in blood pressure.

Study Timeline

• Study Start: 2022-04-26
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Subjects must be able to understand and provide an informed consent to participate.
• Subject must be willing and able to comply with the study procedures.
• Subject must be ≥ 50 and <80 years of age.
• At least 30% of subjects shall be male and at least 30% of subjects shall be female.
• Subject with an arm circumference in the range of the reference device cuff selection.
• Subject with a wrist circumference in the range of the IMD wrist size selection.

Exclusion Criteria

• Subjects with physical characteristics that (e.g. tattoos, scarification, unusual bone structure) may prevent proper application of the device under test.
• Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
• Patients with known sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy, and trigeminy), and left bundle branch block.
• Patients with implantable defibrillators, pacemakers, neurostimulators, or other implantable or worn devices which may interfere with the Polso™ Watch or be affected by the Polso™ Watch in normal operation and use.
• Patients with known Parkinson's disease, essential tremor, convulsive disorders, or other disorder which prevents them from keeping their forearm at rest.
• Patients with known elevated levels of Methemoglobin (MetHb) or Carboxyhemoglobin (COHb), or with anomalous hemoglobin.
• Patients with known severe anemia.
• Subjects with clinically apparent compromised circulation or peripheral vascular disease
• Subjects with clotting disorders or taking anticoagulants other than daily small doses of aspirin or similar
• Subjects that cannot tolerate sitting for up to 1 hour.
• Subjects that cannot perform the required blood pressure induced change procedure.
• Subject with a blood pressure (and other physiological parameters) demographic that has already been filled.
• Subjects with a known allergy to plastic, metals, and/or rubber.
• Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of non-invasive blood pressure cuff.
• Subjects who are pregnant.
• Subjects with BMI >35
• Subjects with BMI <20
• Subjects who gained or lost of >10% of their weight over a period of the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement	Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement	Mean difference between the Polso™ Watch and reference measurement, and the associated standard deviation using data from the rest and induced change measurements following initialization

Primary Outcome Measures

Name	Time	Method
Primary Objectives: Main objective of the study is to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement over time frame of 1 month average.	Through study completion, 1 month average	Blood pressure measurements (units: mmHg) using the Polso™ Watch device will be taken and compared to reference blood pressure measurements taken at the same time using dual auscultatory blood pressure measurements, to show their accuracy and stability.

Trial Locations

Locations (1)

IPPMed - Institute for Pharmacology and Preventive Medicine GmbH; 🇩🇪 Cloppenburg, Low Saxony, Germany