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

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.
 
ClinicalTrials.gov Identifier: NCT01605006
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Synapse Biomedical

Tracking Information
First Submitted Date  ICMJE May 22, 2012
First Posted Date  ICMJE May 24, 2012
Last Update Posted Date March 27, 2020
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
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.)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis
Official Title  ICMJE HDE Post-Approval Study (PAS) of NeuRx DPS for ALS
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE 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
Study Arms  ICMJE NeuRx Diaphragm Pacing System (DPS)
Surgical implantation of the NeuRx DPS (on label use).
Intervention: Device: NeuRx Diaphragm Pacing System (DPS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2016)
97
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2012)
60
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01605006
Other Study ID Numbers  ICMJE CLIN 20-0009-0020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Synapse Biomedical
Study Sponsor  ICMJE Synapse Biomedical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert G. Miller, M.D. Forbes Norris MDA/ALS Research Center, California Pacific Medical Center
PRS Account Synapse Biomedical
Verification Date March 2020

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