NCT01350297

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

3.3 years

First QC Date

February 2, 2010

Last Update Submit

June 17, 2013

Conditions

Tetraplegia

Keywords

tetraplegiareinnervationphrenic nerve

Outcome Measures

Primary Outcomes (1)

  • recovery of spontaneous ventilation

    2 years

Study Arms (1)

Patients

EXPERIMENTAL

Patients

Procedure: reinnervation

Interventions

reinnervationPROCEDURE

anastomosis between right inferior laryngeal nerve and right phrenic nerve

Also known as: laryngeal reinnervation
Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • tetraplegia c3-c4
  • respiratory insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VERIN

Rouen, 76031, France

Location

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • VERIN Eric, MD

    University Hospital, Rouen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2010

First Posted

May 9, 2011

Study Start

March 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

FR(1)