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Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency (TETRADIA-UNI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350297
First Posted: May 9, 2011
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  Purpose
This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.

Condition Intervention Phase
Tetraplegia Procedure: reinnervation Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • recovery of spontaneous ventilation [ Time Frame: 2 years ]

Enrollment: 5
Study Start Date: March 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
Patients
Procedure: reinnervation
anastomosis between right inferior laryngeal nerve and right phrenic nerve
Other Name: laryngeal reinnervation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tetraplegia c3-c4
  • respiratory insufficiency

Exclusion Criteria:

  • PM
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350297


Locations
France
VERIN
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Study Chair: VERIN Eric, MD University Hospital, Rouen
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01350297     History of Changes
Other Study ID Numbers: 2009/023/HP
First Submitted: February 2, 2010
First Posted: May 9, 2011
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by University Hospital, Rouen:
tetraplegia
reinnervation
phrenic nerve

Additional relevant MeSH terms:
Respiratory Insufficiency
Quadriplegia
Respiration Disorders
Respiratory Tract Diseases
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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