Loading clinical trials...

Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data | Clinical Trials | Clareo Health

COMPLETEDNA

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

A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings

NCT03257189•MC10 Inc.

View on ClinicalTrials.gov

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, 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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female volunteers, at least 18 years of age at the time of screening visit;
•2. Fluent in English;
•3. The subject is willing to comply with the protocol specified evaluations;
•4. Subject is willing and cognitively able to sign informed consent

Exclusion Criteria

•1. Pregnancy;
•2. Positive urine drug screen
•3. History of active (clinically significant) skin disorders;
•4. History of allergic response to silicones or adhesives;
•5. Subjects with electronic implants of any kind (e.g. pacemaker)
•6. History of sleep disorders or self-reported insomnia or other sleep conditions;
•7. Broken, damaged or irritated skin or rashes near the sensor application sites;
•8. Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
•9. Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.

Locations (1)

CTI Clinical Research Center

Cincinnati, Ohio, United States

Key Dates

Start Date

July 31, 2017

Primary Completion Date

August 25, 2017

Completion Date

August 30, 2017

Last Updated

January 25, 2019

Enrollment

ACTUAL participants

Conditions

Healthy Normals

Interventions

Physiological signal monitor

DEVICE

Heart rate and heart rate variability comparison device

DEVICE

Respiration rate comparison device

DEVICE

Activity classification

OTHER