Follow-Up to the Usability Evaluation of a Portable Oxygen Concentrator
Follow-Up to Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator System
1 other identifier
observational
4
1 country
1
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 Oxygen Concentrator (POC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2020
CompletedFirst Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedApril 24, 2020
April 1, 2020
Same day
April 21, 2020
April 21, 2020
Conditions
Outcome Measures
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.
2 hours
Interventions
Portable Oxygen Concentrator (POC)
Eligibility Criteria
The study population It is patients requiring supplemental oxygen, as prescribed by a physician.
You may qualify if:
- years or older.
- Male or female.
- Suitable for supplemental oxygen use from a suitably qualified and licensed medical professional.
- Voluntarily signed subject consent form.
You may not qualify if:
- Company employee.
- Former human factors study participants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Belluscura LLClead
Study Sites (1)
Belluscura LLC
Plano, Texas, 75024, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
March 4, 2020
Primary Completion
March 4, 2020
Study Completion
March 4, 2020
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share