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

This study has been completed.
Sponsor:
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
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350297

Locations
France
VERIN
Rouen, France, 76031
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 17, 2013
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:
Respiratory Insufficiency
Quadriplegia
Respiration Disorders
Respiratory Tract Diseases
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014