Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

Phase 2

• Conditions: Vocal Cord Paralysis

• Registration Number: NCT00213863
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Start: 2010-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02
• Primary Completion: 2016-05
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre; 🇫🇷 Strasbourg, France