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Trial record 3 of 5 for:    NeuRx Diaphragm Pacing System

Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605006
First Posted: May 24, 2012
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Synapse Biomedical
May 22, 2012
May 24, 2012
April 13, 2016
July 2012
September 2017   (Final data collection date for primary outcome measure)
Safety Outcome Measure -- Occurrence of major device-related (including procedure-related) adverse events as defined below. [ Time Frame: follow-up assessments at 3-month intervals ]
  • Serious capnothorax requiring invasive intervention
  • Mechanical ventilation for 24 hours or longer post-procedure
  • Post-procedure extubation failure resulting in permanent tracheostomy ventilation
  • Perioperative complication which delays initiation of NeuRx DPS therapy
  • Severe discomfort due to stimulation which is unable to be tolerated or resolved
  • Device malfunction which interrupts or causes an undesired diminution of NeuRx DPS therapy
  • Electrode dislodgement from the diaphragm
  • Wire infection
  • Any other device- or procedure-related serious adverse event
Same as current
Complete list of historical versions of study NCT01605006 on ClinicalTrials.gov Archive Site
Probable Benefit Outcome Measure [ Time Frame: follow-up assessments at 3-month intervals ]
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.)
Same as current
Not Provided
Not Provided
 
Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis
HDE Post-Approval Study (PAS) of NeuRx DPS for ALS
This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who are successfully implanted with the device will use it for daily diaphragm conditioning sessions. Participants will be followed for at least two years (until the last enrolled participant reaches the 2-year follow-up visit). Safety and probable benefit outcome measures will be assessed.
This is a prospective, non-randomized, open-label, interventional, post-approval (FDA) study of the NeuRx Diaphragm Pacing System (DPS) device. The study will enroll 60 participants who have amyotrophic lateral sclerosis (ALS), meet the FDA-approved device indications for use, and undergo the surgical implantation procedure to receive the device. The device is intended for use in ALS patients with a stimulatable diaphragm (both right and left portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and who are experiencing chronic hypoventilation (CH), but not progressed to an FVC less than 45% predicted. Participants who are successfully implanted with the device will use it for daily diaphragm conditioning sessions. Participants will be followed for at least two years (until the last enrolled participant reaches the 2-year follow-up visit). Safety and probable benefit outcome measures will be assessed. The primary objective of the study is: (1) (Safety) Characterize the types and frequency of major device-related adverse events (AEs) over the time of device use. Secondary objectives of the study are: (2) (Safety) Determine whether the frequency of major device-related AEs increases dramatically toward end of life; and (3) (Probable Benefit) Determine whether there is a relationship between survival time and onset type (bulbar and limb), time from onset to treatment, and use of NIV, riluzole, or PEG in patients treated with the device.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis (ALS)
Device: NeuRx Diaphragm Pacing System (DPS)
The NeuRx DPS is a percutaneous, intramuscular, diaphragm stimulation system which is implanted using standard laparoscopic surgical techniques in an outpatient procedure. The implanted intramuscular diaphragm electrodes are connected to a four channel external stimulator at a percutaneous exit site. DPS is designed to help ALS patients breathe by providing conditioning stimulation of the diaphragm muscles. Recommended frequency of diaphragm conditioning is at least 3 times per day with each session lasting at least 30 minutes. Patients may find it helpful to use the DPS for longer periods to help with breathing. DPS may be used at the same time as non-invasive ventilation. Patents may also sleep with the DPS to assist with breathing difficulties at night.
Other Names:
  • diaphragm pacing
  • diaphragmatic pacing
  • phrenic nerve stimulation
NeuRx DPS On-Label Treatment
All study participants who meet the study eligibility criteria will undergo the surgical implantation procedure to receive the NeuRx DPS. Participants who are successfully implanted with the electrodes will use the NeuRx DPS system for diaphragm conditioning.
Intervention: Device: NeuRx Diaphragm Pacing System (DPS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
97
September 2017
September 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 21 or older.
  2. Participants with familial or sporadic ALS diagnosed as laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria.
  3. Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve conduction times.
  4. Chronic hypoventilation was documented by at least one of the following:

    • FVC less than 50% predicted, or
    • |MIP| less than 60 cmH2O, or
    • PaCO2 greater than or equal to 45 mmHg, or
    • Nocturnal SaO2 less than or equal to 88% for at least five continuous minutes
  5. Suitable surgical candidate.
  6. Negative pregnancy test in female participants of childbearing potential.
  7. Informed consent from patient or designated representative.

Exclusion Criteria:

  1. Underlying cardiac or pulmonary disease that would increase the risk of general anesthesia.
  2. Underlying pulmonary diseases that were present prior to ALS that would affect pulmonary tests independent of ALS.
  3. Uncontrolled excessive secretions.
  4. FVC less than 45% predicted at time of surgery.
  5. Preexisting implanted electrical device such as pacemaker or cardiac defibrillator.
  6. Pre-existing diaphragm abnormality such as a hiatal hernia or paraesophageal hernia of abdominal contents going into the thoracic cavity.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01605006
CLIN 20-0009-0020
No
Not Provided
Not Provided
Synapse Biomedical
Synapse Biomedical
Not Provided
Principal Investigator: Robert G. Miller, M.D. Forbes Norris MDA/ALS Research Center, California Pacific Medical Center
Synapse Biomedical
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP