Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked
NCT ID: NCT03725462
Last Updated: 2019-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-10-16
2019-04-16
Brief Summary
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It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Cardioskin
Subjects performed a monitoring with Cardioskin. The performance is evaluated either by a comparison with a gold standard, either by a comparison with anterior version of Cardioskin, either by an opinion of an expert.
Cardioskin
Subjects have a monitoring with cardioskin and comparator
Neuronaute
Subjects performed a monitoring with Neuronaute. The performance is evaluated either by a comparison with a gold standard, either by a comparison with anterior version of Neuronaute, either by an opinion of an expert.
Neuronaute
Subjects have a monitoring with Neuronaute and comparator
Interventions
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Cardioskin
Subjects have a monitoring with cardioskin and comparator
Neuronaute
Subjects have a monitoring with Neuronaute and comparator
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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BioSerenity
INDUSTRY
Responsible Party
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Locations
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ICM
Paris, , France
Countries
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Other Identifiers
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2017-A00648-45
Identifier Type: -
Identifier Source: org_study_id
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