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

Supplemental Oxygen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358848
• Other study ID #: BELL_XPLO2R_FU
• Status: Completed
• Start date: March 4, 2020
• Est. completion date: March 4, 2020

Study information

• Verified date: April 2020
• Source: Belluscura LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Supplemental Oxygen

Intervention

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

Locations

Country	Name	City	State
United States	Belluscura LLC	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Belluscura LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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