NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS)
NCT03034317 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2020-03-26
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.
Conditions
Interventions
- DEVICE
-
NeuRx DPS
Patients who are diagnosed with ALS, have initiated NIV and choose to have the NeuRx DPS implanted.
Sponsors & Collaborators
-
Synapse Biomedical
lead INDUSTRY
Principal Investigators
-
Robert Miller, MD · California Pacific Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-02
- Primary Completion
- 2018-02-08
- Completion
- 2018-02-12
- FDA Device
- Yes
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