Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004415
Status:
TERMINATED
Last Update Posted:
2015-04-07
First Post:
1999-10-18
Brief Title:
Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients
Sponsor:
Case Western Reserve University
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2002-09
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 I Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone
II Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients
II Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients
Detailed Description:
PROTOCOL OUTLINE Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall
If substantial inspired volumes can be generated by intercostal pacing a phrenic nerve cuff electrode and radiofrequency receiver are implanted and patients undergo combined intercostal muscle and diaphragm pacing
Completion date provided represents the completion date of the grant per OOPD records
If substantial inspired volumes can be generated by intercostal pacing a phrenic nerve cuff electrode and radiofrequency receiver are implanted and patients undergo combined intercostal muscle and diaphragm pacing
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CWRU-FDR000403 | None | None | None |
| CWRU-09169-M-91 | None | None | None |