NCT00213616

Brief Summary

Bilateral laryngeal reinnervation induces a rise in laryngeal resistance and speech alteration. The aim of this study is to propose laryngeal reinnervation by a phrenic nerve root to patients with bilateral laryngeal paralysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

6.8 years

First QC Date

September 13, 2005

Last Update Submit

June 17, 2013

Conditions

Vocal Cord Paralysis

Keywords

bilateral vocal cord paralysisreinnervationphrenic nerve

Outcome Measures

Primary Outcomes (1)

  • LARYNGEAL REINNERVATION

    6 months

Interventions

surgical reinnervationPROCEDURE

laryngeal reinnervation with a phrenic nerve root

Eligibility Criteria

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

You may qualify if:

  • Bilateral laryngeal paralysis without any amelioration for six months

You may not qualify if:

  • Laryngeal paralysis more than 3 years
  • Arycricoideus ankylostosis
  • Pacemaker
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean Paul Marie, MD, PHD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2004

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

FR(1)