Follow-Up to the Usability Evaluation of a Portable Oxygen Concentrator

Follow-Up to Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator System

This study was a follow-up evaluation of modifications made to the instructions in the User Manual following the initial study evaluating how well an individual can put together and use a Portable Oxygen Concentrator (POC).

Study Overview

• Status: Completed
• Conditions: Supplemental Oxygen
• Intervention / Treatment: Device: X-PLO2R

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.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75024
      • Belluscura LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population It is patients requiring supplemental oxygen, as prescribed by a physician.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to correctly assemble and use the X-PLO2R POC	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.	2 hours

Collaborators and Investigators

• Sponsor: Belluscura LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BELL_XPLO2R_FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes