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Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04299178
Study type Observational
Source Belluscura LLC
Contact
Status Completed
Phase
Start date February 10, 2020
Completion date February 14, 2020

See also
  Status Clinical Trial Phase
Completed NCT04358848 - Follow-Up to the Usability Evaluation of a Portable Oxygen Concentrator
Completed NCT02464917 - Supplemental Oxygen Study N/A
Completed NCT03366857 - Effect of Supplemental Oxygen on Perioperative BNP Concentration in Cardiac Risk Patients Phase 4