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NCT01350297 Clinical Trial

Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency

Tetraplegia Clinical Trial

— TETRADIA-UNI  

Official title:
Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01350297
Other study ID # 2009/023/HP
Secondary ID
Status Completed
Phase Phase 4
First received February 2, 2010
Last updated June 17, 2013
Start date March 2010
Est. completion date June 2013

Study information
Verified date June 2013
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- tetraplegia c3-c4

- respiratory insufficiency

Exclusion Criteria:

- PM

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• reinnervation
anastomosis between right inferior laryngeal nerve and right phrenic nerve

Locations
Country Name City State
France VERIN Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary recovery of spontaneous ventilation 2 years No
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