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A Novel Non-interfering Arterial Blood Pressure Monitoring Device

NCT01954446 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-10-01

No results posted yet for this study

Summary

The primary purpose of this investigation is to validate the performance and safety of the Investigational Device (ID) against a validated and legally cleared device for measuring Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a period of 24 hours against a validated and legally cleared device for Ambulatory Blood Pressure Monitoring (ABPM).

Conditions

Interventions

DEVICE

3M

Conventional measuring of BP

DEVICE

ContiPressTM

New way of measuring BP - ContiPressTM Investigational device

DEVICE

Mobil-O-Graph

2 different devices for oscillometric measurement of BP

Sponsors & Collaborators

  • Sense A/S

    lead INDUSTRY

Principal Investigators

  • Michael H Olsen, Prof. MD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01954446 on ClinicalTrials.gov