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NCT01596023 · ClinicalTrials.gov registry record · NA
Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients
A NA study, sponsored by Breathe Technologies.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT01596023: Completed NA study, sponsored by Breathe Technologies.
NCT01596023 is a NA study that has completed, run by Breathe Technologies. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596023, a NA study, has completed, sponsored by Breathe Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.
Primary Outcome
Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration
Interventions
- DEVICE Breathe NIOV Ventilator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-12 |
| Phase | NA |
What the finished NCT01596023 record still lists
NCT01596023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Breathe NIOV Ventilator is the first listed.
NCT01596023 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596023 about?
NCT01596023 is a clinical study titled "Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients". The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. Th...
What is the current status of trial NCT01596023?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2012-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01596023?
The interventions under investigation include: Breathe NIOV Ventilator (DEVICE).
Who is sponsoring clinical trial NCT01596023?
This trial is sponsored by Breathe Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01596023's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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