Status:

COMPLETED

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

Lead Sponsor:

Belluscura LLC

Conditions:

Supplemental Oxygen

Eligibility:

All Genders

18+ years

Brief 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 Oxy...

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 Diseas...

Eligibility Criteria

Inclusion

  • 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

  • Company employee.
  • Former human factors study participants.

Key Trial Info

Start Date :

March 4 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 4 2020

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT04358848

Start Date

March 4 2020

End Date

March 4 2020

Last Update

April 24 2020

Active Locations (1)

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1

Belluscura LLC

Plano, Texas, United States, 75024