Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation (BP)

Polso™ Watch BP Accuracy With BP Change Validation ChroniSense Study - IPPMed 1/2021

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Polso™ Watch blood pressure measurement 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 Type: Interventional
• Enrollment (Estimated): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Low Saxony
    • Cloppenburg, Low Saxony, Germany, 49661
      • IPPMed - Institute for Pharmacology and Preventive Medicine GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement; The referenced blood pressure measurements are taken by dual auscultators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Through study completion, 1 month average

Collaborators and Investigators

• Sponsor: ChroniSense Medical Ltd.
• Collaborators: IPPMed, Institute for Pharmacology and Preventive Medicine GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Polso™ Watch BP Accuracy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No