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CompletedNCT04299178Updated Mar 6, 2020

Usability Evaluation of a Portable Oxygen Concentrator

An observational study in Supplemental Oxygen, sponsored by Belluscura LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-06.

Sponsored by Belluscura LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Supplemental Oxygen
03

In context

Lead sponsor

Belluscura LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Company employee.
  • Former human factors study participants.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Interventions

  • DeviceX-PLO2R POC

    Portable Oxygen Concentrator (POC)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 hours

07

Study locations

1 site
  • Belluscura LLC
    Plano, Texas 75024, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04299178
Lead sponsor
Belluscura LLC
Responsible party
Sponsor
First posted
Mar 6, 2020
Start date
Feb 10, 2020
Primary completion
Feb 14, 2020
Completion
Feb 14, 2020
Last update
Mar 6, 2020

Study contacts

Elvira Cawthon, MS
principal investigator

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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