Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency (TETRADIA-UNI)
This study has been completed.
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01350297
First received: February 2, 2010
Last updated: June 17, 2013
Last verified: June 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 2, 2010 | ||||
| Last Updated Date | June 17, 2013 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
recovery of spontaneous ventilation [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01350297 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency | ||||
| Official Title ICMJE | Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction | ||||
| Brief Summary | This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Tetraplegia | ||||
| Intervention ICMJE | Procedure: reinnervation
anastomosis between right inferior laryngeal nerve and right phrenic nerve
Other Name: laryngeal reinnervation |
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| Study Arm (s) | Experimental: Patients
Patients
Intervention: Procedure: reinnervation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5 | ||||
| Completion Date | June 2013 | ||||
| Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01350297 | ||||
| Other Study ID Numbers ICMJE | 2009/023/HP | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital, Rouen | ||||
| Study Sponsor ICMJE | University Hospital, Rouen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Rouen | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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