NCT05735210

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

January 29, 2023

Last Update Submit

March 6, 2024

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

The referenced blood pressure measurements are taken by dual auscultators.

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

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IPPMed - Institute for Pharmacology and Preventive Medicine GmbH

Cloppenburg, Low Saxony, 49661, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 21, 2023

Study Start

April 26, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)