Supplemental Oxygen Clinical Trial
Official title:
Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator (POC) System
Verified date | March 2020 |
Source | Belluscura LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Belluscura LLC | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Belluscura LLC |
United States,
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 |
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