Expired Study
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Englewood, Colorado 80113


Purpose:

OBJECTIVES: The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The hypothesis being tested in the clinical trial is that laparoscopic stimulation of the diaphragm at the motor point with intramuscular electrodes is safe and effective in providing significant ventilatory support to individuals who are otherwise dependant on a mechanical ventilator. Patients in our initial study group have all suffered from high-level spinal cord injury and were full-time dependant on positive pressure mechanical ventilation prior to inclusion.


Study summary:

System: NeuRx RA/4 Diaphragm Pacing Stimulation System Summary: The NeuRx-RA/4 is intended to be used by individuals that have sustained a spinal cord injury, requiring aid with respiration. The device connects to the diaphragm which delivers current to stimulate muscle contractions to aid in respirations. This device currently holds an Investigational Device Exemption No. G920162 in the United States and is currently undergoing clinical trials at University Hospitals (Cleveland), Shepherd Center (Atlanta) and Vancouver (Canada). Introduction: The purpose of the study is to determine if a new, investigational diaphragm pacing system can provide part or full time respiratory support to spinal cord injured persons who normally need a mechanical ventilator. Patients with high-level spinal cord injuries typically experience chronic ventilatory insufficiency due to respiratory muscle paralysis; these patients must be supported predominantly through positive pressure mechanical ventilation with a ventilator. The diaphragm pacing system (NeuRx-RA/4) provides an electrical signal to the motor point of the muscle that causes the diaphragm to contract and allows patients to breathe more naturally. Synapse Biomedical, in conjunction with Case Western Reserve University and University Hospitals of Cleveland, are evaluating activating the diaphragm with percutaneous intramuscular electrodes implanted laparoscopically. This eliminates any direct contact with the phrenic nerve, allows all circuitry and electronics to remain outside the body, and provides direct, selective activation to each hemidiaphragm. The NeuRx RA/4 Diaphragm Pacing Stimulation (DPS) System has been implanted in over 25 individuals with high-level spinal cord injury, resulting in over 20 years of cumulative active implantation time. The longest term patient was implanted March 6, 2000 and has been using the DPS System as his sole means of respiratory support for over five years. With the exception of the second patient, who does not meet our revised inclusion criteria and has gained no benefit from the implant, all of the remaining patients have been able to achieve significant tidal volumes with the DPS System. Based on the current results, the NeuRx RA/4 DPS System has demonstrated safety and efficacy in patients with high-level spinal cord injury. Given the results to date the study has demonstrated preliminary efficacy in this patient population. With no unexpected significant adverse events reported the NeuRx RA/4 DPS System has performed reliably and safely in this patient population. Device Description: The NeuRx RA/4 Respiratory System is manufactured by Synapse Biomedical. The NeuRx RA/4 System comprises the following components: an external, battery powered Stimulator Device, an associated Programmer/Controller, Intramuscular Electrodes, associated percutaneous Lead Wires, a Surgical Placement Tool Set, and a surgical Mapping Station. Inclusion Criteria: - Age 18 years or older - Cervical spinal cord injury dependant on mechanical ventilation - Clinically stable following acute spinal cord injury - Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times - Diaphragm movement with stimulation visible under fluoroscopy - Clinically acceptable oxygenation on room air (>90%) - Hemodynamically stable - No medical co-morbidities that would interfere with the proper placement or function of the device - Committed primary caregiver - Negative pregnancy test in females of child-bearing potential - Informed consent from patient or designated representative Exclusion Criteria: - Co-morbid medical conditions that preclude surgery - Active lung disease (obstructive, restrictive or membrane diseases) - Active cardiovascular disease - Active brain disease - Hemodynamic instability or low oxygen levels on room air - Hospitalization for or a treated active infection within the last 3 months - Significant scoliosis or chest deformity - Marked obesity - Anticipated poor compliance with protocol by either patient or primary caregiver. - Currently breastfeeding


Criteria:

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - High cervical spinal cord injury resulting in tetraplegia - Respiratory failure that requires chronic mechanical ventilatory support - Failure of vigorous attempts to wean from ventilatory support Normal bilateral phrenic nerve function required --Patient Characteristics-- Performance status: Stable condition Cardiovascular: No active cardiovascular disease Pulmonary: No active lung disease Other: - No active brain disease - No significant scoliosis, chest wall deformity, or obesity


Study is Available At:


Original ID:

CLIN 20-0000-0009


NCT ID:

NCT00010374


Secondary ID:


Study Acronym:


Brief Title:

Electrical Activation of The Diaphragm for Ventilatory Assist


Official Title:

Multi-Center Pivotal Study of NeuRx RA/4 Ventilatory Assist Device


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Synapse Biomedical


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Raymond Onders, MD
Principal Investigator
University Hospitals of Cleveland

Study Dates

Start Date:February 2000
Completion Date:October 2008
Completion Type:Anticipated
Primary Completion Date:October 2008
Primary Completion Type:Anticipated
Verification Date:September 2008
Last Changed Date:September 15, 2008
First Received Date:February 2, 2001

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Reduction of dependence on mechanical ventilation. Improvement in the quality of life for patient and caregiver.
Time Frame:Within one year of implantation
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Adverse event rate from time of electrode implant compared to published adverse event rates in a similar patient population using ventilator support.
Time Frame:After completion of the study
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Clinically acceptable tidal volume sustained over a continuous 4 hour period.
Time Frame:Within one year after implantation
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:intramuscular diaphragm electrodes
Description:Conditioning of the diaphragm
Arm Name:1
Intervention Type:Device
Name:Intramuscular diaphragm electrodes
Description:to test the safety, efficacy and clinical utility of diaphragm pacing using IM electrodes placed through a laparoscopic approach to achieve artificial ventilation in spinal cord injured patients who have an internal cardiac pacemaker and require full-time ventilator support.
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:The objective of this study is to assess the safety and efficacy of the NeuRx RA/4 for diaphragm pacing compared to mechanical ventilator support.
Study Arm Type:Experimental
Arm Name:2
Description:To test the safety, efficacy and clinical utility of diaphragm pacing using IM electrodes placed through a laparoscopic approach to achieve artificial ventilation in spinal cord injured patients who have an internal cardiac pacemaker and require full-time ventilator support.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Synapse Biomedical
Agency Class:Other
Agency Type:Collaborator
Agency Name:University Hospitals of Cleveland

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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