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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03725462
Other study ID # 2017-A00648-45
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2017
Est. completion date April 16, 2019

Study information

Verified date February 2019
Source BioSerenity
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim is to evaluate the performance of Cardioskin and Neuronaute, two connected medical devices CE-marked, manufactured by Bioserenity.

It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.


Description:

With this study evulating the performance of two wireless, connected device of electrophysiological signal monitoring. The Cardioskin monitors electrocardiogram signal. The Neuronaute monitors electroencephalogram, electromyogram and electrocardiogram.

This study will permit to optimize the devices performance.

To the study, subjects of at least 18 years old will test Cardioskin and or Neuronaute device, without randomization.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 16, 2019
Est. primary completion date March 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

• man or women of at least 18 years old

Exclusion Criteria:

- Injuries or wounds on the body and scalp

- Participant unable to follow the procedure of use, the judgment of the investigator

- Brain surgery that occurred less than a week ago

- Known allergy to silver, polyamide, silicone, synthetic materials

- Sensory disorders that make the subject insensitive to pain

- behavioral problems that make the subject excessively agitated or aggressive;

- Cardiorespiratory disorders that may be aggravated by mild compression of thorax

- Subject equipped with an electrical stimulation device;

- Inappropriate anthropometric parameters to textile sizes

- Clinically detectable or known pain of the subject;

- Current participation in a clinical trial or participation in a previous clinical study including a period of deficiency not yet completed at the time of this clinical trial

- Predisposition to tension headaches (the compression exerted by the cap may in some cases trigger a headache);

- Use of the Cardioskin device for resuscitation or intensive care.

- Participant with defibrillator, vagus nerve stimulator or other high frequency surgical device

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cardioskin
Subjects have a monitoring with cardioskin and comparator
Neuronaute
Subjects have a monitoring with Neuronaute and comparator

Locations

Country Name City State
France ICM Paris

Sponsors (1)

Lead Sponsor Collaborator
BioSerenity

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensor quality validation Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns (eg.beat detection, beats variability..) 2 month
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