NCT02934386

Brief Summary

The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to the existing CE-marked WinPack device, compared to two reference devices (one oscillometric and one volume-clamp device), in healthy subjects and patients undergoing a standardized physical-activity hypertensive protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

October 13, 2016

Last Update Submit

November 23, 2017

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Assessment of the accuracy of a novel algorithm to extract BP estimates from data acquired by the WinPack system, when compared to gold-standard BP devices, with respect to limits of agreement as stated by the IEEE 1708:2014 standard

    3 Months

Study Arms (1)

WinMedical WinPack device

EXPERIMENTAL

50 volunteers undergoing experimental protocol according to IEEE 1708:2014 standard

Device: WinMedical WinPack device

Interventions

WinMedical WinPack deviceDEVICE
WinMedical WinPack device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Informed Consent
  • Compliant and able to protocol manoeuvres

You may not qualify if:

  • Blood pressure difference between to arms \>15mmHg
  • Current or history of tobacco smoking (for the last 5 years, \> 5 cigarettes per day),
  • Current alcohol or drug abuse (\>4 units per day),
  • Unstable cardiac condition (myocardial infarction \< 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
  • Severe anaemia (haemoglobin \<100g/l)
  • Oxygen therapy
  • Lesion or deficiency on left hand, preventing to perform handgrip exercises
  • Lesion or deficiency on both legs, preventing to perform leg extension exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HNE - Hôpital Neuchâtelois, Site de Pourtalès

Neuchâtel, 2000, Switzerland

Location

Study Officials

  • Cyril Pellaton, Dr

    HNE - Hôpital Neuchâtelois, Site de Pourtalès

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 17, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)