Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data

Completed · Not applicable

Conditions studied: Healthy Normals

In brief

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, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.

Key facts

Study ID: NCT03257189
Run by: MC10 Inc.
People needed: 30
Starts: 2017-07-31
Expected to finish: 2017-08-30
Last updated by the study team: 2019-01-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

CTI Clinical Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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