MedTrace Logo

Spire Health Remote Patient Monitor Human Factors Summative Study Protocol

NCT06395350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-05-02

No results posted yet for this study

Summary

This usability validation testing protocol outlines the methods being used to demonstrate and gather evidence that the current design and user experience of the Spire Remote Patient Monitor are safe and effective for use by the people who are representative of the intended users under expected use conditions. This summative testing is the culmination of several preliminary analyses including a formative usability evaluation via Cognitive Expert Review Panel and is intended to assess the effectiveness of control measures put in place to reduce/eliminate use-related hazards or potential use errors.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

Spire Health Monitor

Use of Health Monitor is Assessed

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Spire, Inc.

    lead INDUSTRY

Principal Investigators

  • Arthur Cabrera, MD · Medical Director for Clinimark LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2019-09-20
Completion
2019-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06395350 on ClinicalTrials.gov