Accuracy of the RIVA Digital Blood Pressure Measurement A... | NCT04461834

Studies
Accuracy of the RIVA Digital Blood Pressure Measurement App - a Pilot Study

NCT04461834

Sponsor

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Status

Completed

Last Update Posted

Oct 1, 2020Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Blood Pressure

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2020Actual

Primary Completion Date

Sep 24, 2020Actual

Completion Date

Sep 24, 2020Actual

First Submitted Date

Jul 2, 2020

First Submission Date that Met QC Criteria

Jul 2, 2020

First Posted Date

Jul 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2020

Last Update Posted Date

Oct 1, 2020Actual

Name	Class
University Hospital, Basel, Switzerland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the Blood Pressure Measurement 24 hours after calibration will also be tested.

Detailed Description

Conventional blood pressure measurements (BPM) using a cuff-based device are actually gold standard of BPM in clinical practice. Due to availability and patient comfort, the number of such BPM is limited. Considering the large number of people using smartphones, app-based measurements and screening procedures have the potential to increase the availability of BPM and improve blood pressure control, but a prerequisite of the use of these alternative BPM methods is accuracy.

The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the BPM 24 hours after calibration will also be tested.

Before mounting the 24h-Blood Pressure (BP) monitor, a set of 11 BPM will be taken, starting with a conventional BPM using a Welch Allyn Connex® Spot Monitor, then alternating to the app, leading to 6 possible pairs of comparison. The next day, without another calibration of the app, we will take another 3 pairs of comparison (7 alternating measurements, starting with a conventional measurement). Examinators are blinded for the results of the app measurements. The app automatically sends the data of the BPM to RIVA Digital, where the results measured by the app will be processed. The staff of RIVA Digital are blinded to the conventional BPM results.

Number of Participants: 50 consecutive patients will be included in the study.

Statistical analyses: Both BPM procedures are analyzed for correlation and accuracy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Data statistical analysis	Both Blood Pressure Measurement procedures are analysed for correlation and accuracy	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing a 24h-ambulatory blood pressure measurement

Exclusion Criteria:

age < 18 years
impossibility to sign informed consent
physical restrictions to Blood Pressure Measurement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

AIl patients undergoing a 24h-ambulatory blood pressure measurement are eligible.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Mayr, PD Dr.	University Hospital of Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Basel		Basel		4031	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided