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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04299178
Other study ID # BELL_XPLO2R
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 10, 2020
Est. completion date February 14, 2020

Study information

Verified date March 2020
Source Belluscura LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.


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 18
Est. completion date February 14, 2020
Est. primary completion date February 14, 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
X-PLO2R POC
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
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