Clinical trial NCT05735210: Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation
Official title: Polso™ Watch BP Accuracy With BP Change Validation ChroniSense Study - IPPMed 1/2021
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Pressure
Lead sponsor: ChroniSense Medical Ltd.
Sponsor class: INDUSTRY
Collaborators: name: IPPMed, Institute for Pharmacology and Preventive Medicine GmbH
First posted: 2023-02-21
Enrollment: 185
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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.
timeFrame: Through study completion, 1 month average
Secondary outcomes:
Other outcomes:
Locations:
city: Cloppenburg
country: Germany
facility: IPPMed - Institute for Pharmacology and Preventive Medicine GmbH
state: Low Saxony
Study officials:
References: