Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT01350297 |
Date of registration:
|
02/02/2010 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency
TETRADIA-UNI |
Scientific title:
|
Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction |
Date of first enrolment:
|
March 2010 |
Target sample size:
|
5 |
Recruitment status: |
Completed |
URL:
|
http://clinicaltrials.gov/show/NCT01350297 |
Study type:
|
Interventional |
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
Phase:
|
Phase 4
|
|
Countries of recruitment
|
France
| | | | | | | |
Contacts
|
Name:
|
VERIN Eric, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University Hospital, Rouen |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- tetraplegia c3-c4
- respiratory insufficiency
Exclusion Criteria:
- PM
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Tetraplegia
|
Intervention(s)
|
Procedure: reinnervation
|
Primary Outcome(s)
|
recovery of spontaneous ventilation
[Time Frame: 2 years]
|
Secondary ID(s)
|
2009/023/HP
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|