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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: Completed NA study, sponsored by Breathe Technologies.

NCT01347931 is a NA study that has completed, run by Breathe Technologies. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Time in minutes of sustained activity while using test treatments

Interventions

  • DEVICE NIOV System
  • DEVICE Standard Oxygen Cannula

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-05
Est. Completion 2012-03
Phase NA
Breathe Technologies

4 total trials

What the finished NCT01347931 record still lists

NCT01347931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which NIOV System is the first listed.

NCT01347931 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01347931's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 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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Source: ClinicalTrials.gov NCT01347931, the US trial registry maintained by the National Library of Medicine. NCT01347931 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.