NCT00213863

Brief Summary

This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

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
5.2 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

5.4 years

First QC Date

September 13, 2005

Last Update Submit

June 28, 2012

Conditions

Vocal Cord Paralysis

Keywords

porous titanium implantsthyroplastyvocal cord paralysismale or female more than 18 years old

Outcome Measures

Primary Outcomes (3)

  • Nasofibroscopy

    8 days and 3 months after surgery

  • Voice control and recording

    8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial

  • All types of complication

    8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial

Interventions

Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick settingDEVICE

The porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting.

Eligibility Criteria

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

You may qualify if:

  • Males or females greater than 18 years old

You may not qualify if:

  • Age less than 18 years
  • Pregnant women
  • Local carcinoma excluding radiotherapeutic or surgical control
  • Bad general condition
  • Contraindication to general anesthesia
  • Non-controlled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

Vocal Cord Paralysis

Interventions

Laryngoplasty

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Christian Debry, MD

    Hopitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Debry, MD

CONTACT

christian.debry@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
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

December 1, 2010

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

FR(1)