Trials / Withdrawn
WithdrawnNCT03034317
NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS)
Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants With Amyotrophic Lateral Sclerosis (ALS)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Synapse Biomedical · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.
Detailed description
Characterize the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of DPS in patients with ALS who initiated noninvasive ventilation (NIV).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NeuRx DPS | Patients who are diagnosed with ALS, have initiated NIV and choose to have the NeuRx DPS implanted. |
Timeline
- Start date
- 2017-02-02
- Primary completion
- 2018-02-08
- Completion
- 2018-02-12
- First posted
- 2017-01-27
- Last updated
- 2020-03-26
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03034317. Inclusion in this directory is not an endorsement.