Healthy Clinical Trial
— STREAMOfficial title:
Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked
Verified date | February 2019 |
Source | BioSerenity |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | ICM | Paris |
Lead Sponsor | Collaborator |
---|---|
BioSerenity |
France,
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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