Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

Vocal Cord Paralysis Clinical Trial

Official title:

Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00213863
• Other study ID #: 3097
• Status: Recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 28, 2012
• Start date: December 2010
• Est. completion date: November 2016

Study information

• Verified date: June 2012
• Source: University Hospital, Strasbourg, France
• Contact: Christian Debry, MD
• Email: christian.debry[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paralysis
• Vocal Cord Paralysis

Intervention

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.

Locations

Country	Name	City	State
France	Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasofibroscopy		8 days and 3 months after surgery	No
Primary	Voice control and recording		8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial	No
Primary	All types of complication		8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial	Yes