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

NCT03257189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-25

Study results available
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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.

Conditions

  • Healthy Normals

Interventions

DEVICE

Physiological signal monitor

Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.

DEVICE

Heart rate and heart rate variability comparison device

FDA cleared reference device that monitors heart rate and heart rate variability in subjects

DEVICE

Respiration rate comparison device

FDA cleared reference device that monitors respiration rate in subjects

OTHER

Activity classification

Visual annotation of subject posture and other activities used for reference

Sponsors & Collaborators

  • MC10 Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2017-08-25
Completion
2017-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03257189 on ClinicalTrials.gov