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NCT01347931 · ClinicalTrials.gov registry record · NA
In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency
A NA study, sponsored by Breathe Technologies.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01347931 is a NA study that has completed, run by Breathe Technologies. The registered enrollment target is 30 participants.
The verdict
NCT01347931, a NA study, has completed, sponsored by Breathe Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.
Interventions
- DEVICE NIOV System
- DEVICE Standard Oxygen Cannula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01347931
The ClinicalTrials.gov registry entry for NCT01347931 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Breathe Technologies, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NIOV System is the first listed.
NCT01347931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01347931 about?
NCT01347931 is a clinical study titled "In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency". The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combinatio...
What is the current status of trial NCT01347931?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2011-05. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01347931?
The interventions under investigation include: NIOV System (DEVICE), Standard Oxygen Cannula (DEVICE).
Who is sponsoring clinical trial NCT01347931?
This trial is sponsored by Breathe Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
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