Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation

NCT ID: NCT05735210

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2024-07-01

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement

Intervention Type: DEVICE

The referenced blood pressure measurements are taken by dual auscultators.

Interventions

Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement

The referenced blood pressure measurements are taken by dual auscultators.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IPPMed, Institute for Pharmacology and Preventive Medicine GmbH

UNKNOWN

Sponsor Role: collaborator

ChroniSense Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IPPMed - Institute for Pharmacology and Preventive Medicine GmbH

Cloppenburg, Low Saxony, Germany

Countries

Germany

Other Identifiers

Polso™ Watch BP Accuracy

Identifier Type: -

Identifier Source: org_study_id