NCT04358848

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: Belluscura LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Supplemental Oxygen

Interventions

Type	Name	Description
DEVICE	X-PLO2R	Portable Oxygen Concentrator (POC)

Timeline

• Start date: 2020-03-04
• Primary completion: 2020-03-04
• Completion: 2020-03-04
• First posted: 2020-04-24
• Last updated: 2020-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study