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

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01350297
First received: February 2, 2010
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • recovery of spontaneous ventilation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: March 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tetraplegia c3-c4
  • respiratory insufficiency

Exclusion Criteria:

  • PM
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350297

Contacts
Contact: Eric VERIN, MDPhD eric.verin@chu-rouen.fr

Locations
France
VERIN Recruiting
Rouen, France, 76031
Contact: Eric VERIN, MDPhD         eric.verin@chu-rouen.fr    
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Study Chair: VERIN Eric, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01350297     History of Changes
Other Study ID Numbers: 2009/023/HP
Study First Received: February 2, 2010
Last Updated: June 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 23, 2013