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Sponsors and Collaborators: |
Synapse Biomedical University Hospitals of Cleveland Shepherd Center in Atlanta |
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Information provided by: | Synapse Biomedical |
ClinicalTrials.gov Identifier: | NCT00010374 |
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.
Condition | Intervention |
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Spinal Cord Injury Quadriplegia |
Device: intramuscular diaphragm electrodes Device: Intramuscular diaphragm electrodes |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multi-Center Pivotal Study of NeuRx RA/4 Ventilatory Assist Device |
Estimated Enrollment: | 50 |
Study Start Date: | February 2000 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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Device: intramuscular diaphragm electrodes
Conditioning of the diaphragm
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2: Experimental
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.
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Device: intramuscular diaphragm electrodes
Conditioning of the diaphragm
Device: Intramuscular diaphragm electrodes
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Normal bilateral phrenic nerve function required
--Patient Characteristics--
Performance status: Stable condition
Cardiovascular: No active cardiovascular disease
Pulmonary: No active lung disease
Other:
United States, Colorado | |
Craig Hospital | |
Englewood, Colorado, United States, 80113-2811 | |
United States, Georgia | |
Shepherd Center | |
Atlanta, Georgia, United States, 30309-1465 | |
United States, Ohio | |
University Hospital Of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 | |
Canada, British Columbia | |
Vancouver CoastHealth | |
Vancouver, British Columbia, Canada, V5Z 1M9 |
Principal Investigator: | Raymond Onders, MD | University Hospitals of Cleveland |
Responsible Party: | University Hospitals of Cleveland ( Raymond Onders, MD ) |
Study ID Numbers: | CLIN 20-0000-0009 |
Study First Received: | February 2, 2001 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00010374 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Diaphragm for Ventilatory Assist environmental/toxic disorders neurologic and psychiatric disorders rare disease spinal cord injury |
Paralysis Signs and Symptoms Spinal Cord Injuries Spinal Cord Diseases Mental Disorders Wounds and Injuries |
Rare Diseases Disorders of Environmental Origin Central Nervous System Diseases Neurologic Manifestations Trauma, Nervous System Quadriplegia |
Nervous System Diseases |