Supplemental OxygenNCT04299178
Usability Evaluation of a Portable Oxygen Concentrator
An observational study of Supplemental Oxygen, run by Belluscura LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supplemental Oxygen
- What is being tested?
- X-PLO2R POC
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 14 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population It is patients requiring supplemental oxygen, as prescribed by a physician.
Who may be able to join
- 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.
Who cannot join
- Company employee.
- Former human factors study participants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator (POC) System
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.
- Conditions
- Supplemental Oxygen
- Being tested
- X-PLO2R POC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-PLO2R POCDevice
Portable Oxygen Concentrator (POC)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start10 Feb 2020
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supplemental OxygenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belluscura LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elvira Cawthon, MS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299178
- Sponsor's protocol ID
- BELL_XPLO2R
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator (POC) System
- ClinicalTrials.gov ID
- NCT04299178
- Acronym / sponsor ID
- BELL_XPLO2R
- Conditions
- Supplemental Oxygen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Belluscura LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population It is patients requiring supplemental oxygen, as prescribed by a physician.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Company employee.
- Former human factors study participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-PLO2R POCPortable Oxygen Concentrator (POC) | Device | – |
Primary outcome
Ability to correctly assemble and use the X-PLO2R POC
Time frame: 2 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvira Cawthon, MS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supplemental Oxygen, run by Belluscura LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to correctly assemble and use the X-PLO2R POC (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.