Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010374
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2001-02-02
Brief Title:
Electrical Activation of The Diaphragm for Ventilatory Assist
Sponsor:
Synapse Biomedical
Organization:
Synapse Biomedical
Study Overview
Official Title:
Multi-Center Pivotal Study of NeuRx RA4 Ventilatory Assist Device
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
System NeuRx RA4 Diaphragm Pacing Stimulation System
Summary
The NeuRx-RA4 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-RA4 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 RA4 Diaphragm Pacing Stimulation DPS System has been implanted in 49 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 RA4 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 RA4 DPS System has performed reliably and safely in this patient population
Device Description The NeuRx RA4 Respiratory System is manufactured by Synapse Biomedical The NeuRx RA4 System comprises the following components an external battery powered Stimulator Device an associated ProgrammerController 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 dependent 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
Summary
The NeuRx-RA4 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-RA4 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 RA4 Diaphragm Pacing Stimulation DPS System has been implanted in 49 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 RA4 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 RA4 DPS System has performed reliably and safely in this patient population
Device Description The NeuRx RA4 Respiratory System is manufactured by Synapse Biomedical The NeuRx RA4 System comprises the following components an external battery powered Stimulator Device an associated ProgrammerController 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 dependent 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None