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Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

Primary Purpose

Vocal Cord Paralysis

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vocal Cord Paralysis focused on measuring porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Nasofibroscopy
Voice control and recording
All types of complication

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
June 28, 2012
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT00213863
Brief Title
Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
Official Title
Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Paralysis
Keywords
porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nasofibroscopy
Time Frame
8 days and 3 months after surgery
Title
Voice control and recording
Time Frame
8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
Title
All types of complication
Time Frame
8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Debry, MD
Email
christian.debry@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Debry, MD
Organizational Affiliation
Hopitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Debry, MD
Phone
33.3.88.12.76.45
Email
christian.debry@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Christian DEBRY, MD
First Name & Middle Initial & Last Name & Degree
Philippe SCHULTZ, MD

12. IPD Sharing Statement

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Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

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