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Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213863
First received: September 13, 2005
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Vocal Cord Paralysis
 Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Paralysis
U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Nasofibroscopy [ Time Frame: 8 days and 3 months after surgery ] [ Designated as safety issue: No ]
  • Voice control and recording [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial ] [ Designated as safety issue: No ]
  • All types of complication [ Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: December 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females greater than 18 years old

Exclusion Criteria:

  • Age less than 18 years
  • Pregnant women
  • Local carcinoma excluding radiotherapeutic or surgical control
  • Bad general condition
  • Contraindication to general anesthesia
  • Non-controlled diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213863

Contacts
Contact: Christian Debry, MD christian.debry@chru-strasbourg.fr

Locations
France
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre Recruiting
Strasbourg, France
Contact: Christian Debry, MD     33.3.88.12.76.45     christian.debry@chru-strasbourg.fr    
Principal Investigator: Christian DEBRY, MD            
Sub-Investigator: Philippe SCHULTZ, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Christian Debry, MD Hopitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00213863     History of Changes
Other Study ID Numbers: 3097
Study First Received: September 13, 2005
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
porous titanium implants
thyroplasty
vocal cord paralysis
male or female more than 18 years old

Additional relevant MeSH terms:
Vocal Cord Paralysis
Paralysis
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
 Vagus Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013