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CompletedNCT03997461Updated Oct 22, 2019

Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device

An interventional study of BPro in Blood Pressure, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-22.

Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Sep 2018, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
25 Years and older
Sex
All
01

Study summary

The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions

Read the detailed description

The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions. Measurements will be taken at 15 minutes intervals during the day and 30 minutes intervals during the night.

02

Conditions studied

  • Blood Pressure

Keywords

  • Blood Pressure
03

In context

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Able to give informed consent

Exclusion criteria

Exclusion Criteria:

  • Difference in blood pressure between the arms higher than 10 mmHg
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    BPro vs Oscar 2

    Blood pressure measurement with BPro and Oscar 2 simultaneously during 24 hours under ambulatory conditions

    Device: BPro

Interventions

  • DeviceBPro

    BPro and Oscar 2 comparison for 24 hours

06

What researchers measure

Primary outcomes

  1. Difference in systolic blood pressure taken simultaneously by BPro and Oscar 2 devices

    Mean of the absolute differences in systolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours

    Time frame: 24 hours

  2. Difference in diastolic blood pressure taken simultaneously by BPro and Oscar 2 devices

    Mean of the absolute differences in diastolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours

    Time frame: 24 hours

07

Study locations

1 site
  • Institute for Biological and Medical Engineering
    Santiago, Metropolitana 7820436, Chile
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03997461
Lead sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
Responsible party
Sponsor
First posted
Jun 25, 2019
Start date
Sep 26, 2018
Primary completion
Jul 30, 2019
Completion
Jul 30, 2019
Last update
Oct 22, 2019

Study contacts

Maria Rodriguez Fernandez, PhD
principal investigator · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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