Rare Disease Trial, Completed NCT00010374 Sponsor: Synapse Biomedical Condition: Rare Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 54 participants, all placed in a single treatment group. One person did not complete the study, leaving 53 who finished. The trial was testing a device called the NeuRx Diaphragm Pacing System (DPS) — a system that uses small electrical signals to stimulate the diaphragm (the main breathing muscle) in people who rely on a mechanical ventilator to breathe. The main thing the researchers were measuring was whether participants could sustain what was considered a clinically acceptable breathing volume — meaning enough air moved in and out with each breath — over a continuous four-hour period. The reported data shows that, of the enrolled participants, 52 successfully maintained that acceptable breathing volume over a continuous four-hour period, while 1 participant did not. For one of the secondary measurements, the reported average volume of air moved with each breath during device use was 745.6 ml (millilitres). The reported data also shows that 31 participants were recorded as being able to use the NeuRx DPS device for breathing for 24 continuous hours a day without the assistance of a mechanical ventilator. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Rare Disease Trial, Completed

NCT00010374
Completed Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You must be 18 years old or older
  • You must have a spinal cord injury in the neck area and depend on a machine to help you breathe
  • Your condition must be medically stable after the spinal cord injury
  • The nerves that control your breathing (phrenic nerves) on both sides of your body must be working at an acceptable level, confirmed by nerve and muscle tests
  • Your diaphragm (the main breathing muscle) must show movement when stimulated, as seen on an X-ray imaging test
  • Your blood oxygen levels must be at an acceptable level when breathing normal room air (above 90%)
  • Your heart and blood pressure must be stable
  • You must not have any other health conditions that would prevent the device from being placed or working properly
  • You must have a dedicated primary caregiver who is committed to supporting you
  • If you are a woman who could become pregnant, you must have a negative pregnancy test
  • You (or your legal representative) must agree to take part by signing a consent form

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have health conditions that make surgery too risky
  • You have an active lung disease, such as asthma, or other breathing-related conditions
  • You have an active heart or blood vessel disease
  • You have an active brain condition or disease
  • Your blood pressure is unstable or your oxygen levels are too low when breathing normal room air
  • You were hospitalised for an infection or were treated for an active infection in the last 3 months
  • You have a significant curvature of the spine or a chest shape that could cause problems (confirm with trial site)
  • You are significantly overweight in a way that could affect the procedure (confirm with trial site)
  • There are concerns that you or your caregiver may not be able to follow the trial requirements as expected
  • You are currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 August 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Synapse Biomedical
Registry
ClinicalTrials.gov
Start date
1 February 2000
Est. completion
1 October 2008

Where this trial was run

🇨🇦 Canada 🇺🇸 United States

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period.

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov