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|
| General |
| Study Status |
Progress Adequate |
| Application Number |
H100006 / PAS001 |
| Current Plan Approved |
09/28/2011
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| Study Name |
OSB Lead-NeuRx DPS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Design Description |
This is a prospective, non-randomized, open-label, interventional study.
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| Study Population Description |
This study will enroll ALS patients who meet the HDE-approved device indications for use and undergo the surgical implantation procedure to receive the NeuRx DPS System after HDE approval. An important inclusion criterion is that patients must have chronic hypoventilation; an important exclusion criterion is that FVC < 45% predicted at time of surgery.
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| Sample Size |
Based on practical considerations in this small subpopulation of patients with ALS who meet the HDE indications for use, it is expected that 60 participants can be enrolled at 3 to 12 centers over three years. This sample size of 60 participants has 80% power to ensure that the major device-related adverse event rate at 9 months post implant does not exceed 40% (based on peak adverse event rate using same device for spinal cord injury indication [H070003]), assuming the true event rate is 23% (based on IDE), with 5% one-sided alpha. A sample size of 60 patients ensures that there will be at least 48 patients at risk at the beginning of the 6 to 9 months interval to analyze the AE rate at 9 months.
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| Data Collection |
This study will examine the following safety and probable benefit outcomes of interest:
Safety Outcome Measure: Occurrence of major device-related (including procedure-related) adverse events as defined as:
Serious capnothorax requiring invasive intervention (such as chest tube placement).
Mechanical ventilation for 24 hours or longer post-procedure.
Post-procedure extubation failure resulting in permanent tracheostomy ventilation (PTV).
Perioperative complication which delays the initiation of NeuRx DPS therapy.
Severe discomfort due to stimulation which is unable to be tolerated or resolved and results in interruption or discontinuation of NeuRx DPS therapy.
Device malfunction (e.g,. broken wire or stimulator) which interrupts or causes an undesired diminution of NeuRx DPS therapy (e.g., no stimulation in one hemi-diaphragm).
Electrode dislodgement from the diaphragm.
Wire infection.
Any other device- or procedure-related serious adverse event (SAE) that is fatal, life threatening, requires or prolongs hospitalization, or requires intervention to prevent permanent impairment or damage.
Probable Benefit Outcome Measure: Survival, defined as time to (a) death or (b) permanent tracheostomy mechanical ventilation (PTV) with discontinuation of pacing. (All deaths and PTV events will be reported regardless of relationship to the device or procedure.)
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| Follow-up Visits and Length of Follow-up |
9 months
0 to 1 month, 1- 3 months, and every 3 months thereafter until post-implant follow-up completion
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