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

Primary Purpose

Tetraplegia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
reinnervation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tetraplegia focused on measuring tetraplegia, reinnervation, phrenic nerve

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • tetraplegia c3-c4
  • respiratory insufficiency

Exclusion Criteria:

  • PM

Sites / Locations

  • VERIN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Patients

Outcomes

Primary Outcome Measures

recovery of spontaneous ventilation

Secondary Outcome Measures

Full Information

First Posted
February 2, 2010
Last Updated
June 17, 2013
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01350297
Brief Title
Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency
Acronym
TETRADIA-UNI
Official Title
Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia
Keywords
tetraplegia, reinnervation, phrenic nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients
Intervention Type
Procedure
Intervention Name(s)
reinnervation
Other Intervention Name(s)
laryngeal reinnervation
Intervention Description
anastomosis between right inferior laryngeal nerve and right phrenic nerve
Primary Outcome Measure Information:
Title
recovery of spontaneous ventilation
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: tetraplegia c3-c4 respiratory insufficiency Exclusion Criteria: PM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VERIN Eric, MD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Study Chair
Facility Information:
Facility Name
VERIN
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency

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