Usability Evaluation of a Portable Oxygen Concentrator

Overview

This study evaluates how well an individual can put together and use a Portable Oxygen Concentrator (POC) by following the instructions in the User Manual.

Full Title of Study: “Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator (POC) System”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 14, 2020

Detailed Description

The Belluscura X-PLO2R Portable Oxygen Concentrator (POC) is intended for the provision of supplemental oxygen to patients with chronic pulmonary diseases, such as Chronic Obstructive Pulmonary Disease (COPD), and for a patient requiring supplemental oxygen, as prescribed by a physician. The purpose of this study is to evaluate if the X-PLO2R POC can be used by the intended users without serious errors or problems for the intended use and under the expected use conditions. Specifically, the study is to evaluate if potential users of the device can correctly, safely and effectively set-up, activate and operate the X-PLO2R POC to receive the required supplemental oxygen; if the intended user can understand and apply the information contained in the Belluscura X-PLO2R Quick Start Guide and User Manual; and to identify any and all use difficulties, problems and errors made during device assembly and operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification.

Interventions

  • Device: X-PLO2R POC
    • Portable Oxygen Concentrator (POC)

Clinical Trial Outcome Measures

Primary Measures

  • Ability to correctly assemble and use the X-PLO2R POC
    • Time Frame: 2 hours
    • A subject who is able to follow the instructions to correctly assemble and receive oxygen through the X-PLO2R POC will be considered a study pass.A subject who is not able to follow the instructions and does not correctly assemble and receive oxygen through the X-PLO2R POC will be considered a study fail.

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years or older. – Male or female. – Suitable for supplemental oxygen use from a suitably qualified and licensed medical professional. – Voluntarily signed subject consent form. Exclusion Criteria:

  • Company employee. – Former human factors study participants.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Belluscura LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elvira Cawthon, MS, Principal Investigator,

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