NCT04299178

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

4 days

First QC Date

March 5, 2020

Last Update Submit

March 5, 2020

Conditions

Supplemental Oxygen

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

X-PLO2R POCDEVICE

Portable Oxygen Concentrator (POC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Belluscura LLC

Plano, Texas, 75024, United States

Location

Study Officials

  • Elvira Cawthon, MS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 6, 2020

Study Start

February 10, 2020

Primary Completion

February 14, 2020

Study Completion

February 14, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)