Status:
COMPLETED
Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
Lead Sponsor:
MC10 Inc.
Conditions:
Healthy Normals
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements. Study design: A single-site, non-significant risk, o...
Eligibility Criteria
Inclusion
- Male or female volunteers, at least 18 years of age at the time of screening visit;
- Fluent in English;
- The subject is willing to comply with the protocol specified evaluations;
- Subject is willing and cognitively able to sign informed consent
Exclusion
- Pregnancy;
- Positive urine drug screen
- History of active (clinically significant) skin disorders;
- History of allergic response to silicones or adhesives;
- Subjects with electronic implants of any kind (e.g. pacemaker)
- History of sleep disorders or self-reported insomnia or other sleep conditions;
- Broken, damaged or irritated skin or rashes near the sensor application sites;
- Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
- Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03257189
Start Date
July 31 2017
End Date
August 30 2017
Last Update
January 25 2019
Active Locations (1)
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1
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212