Status:
COMPLETED
Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia
Lead Sponsor:
Craig Hospital
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Tetraplegia
Spinal Cord Injury
Eligibility:
All Genders
Brief Summary
This is an observational longitudinal study designed to identify and describe long term outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As this is not a random...
Detailed Description
Ventilatory dependent high tetraplegia is a relatively rare but devastating condition. Review of National Spinal Cord Injury Database statistics show that only 3.6% of patients with tetraplegia are ve...
Eligibility Criteria
Inclusion
- Patients previously incurring a traumatic spinal cord injury resulting in high tetraplegia
- Patients implanted with DPS
Exclusion
- Implementation of DPS prior to 2003
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01815554
Start Date
January 1 2013
End Date
April 1 2016
Last Update
January 31 2017
Active Locations (1)
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1
Craig Hospital
Englewood, Colorado, United States, 80113