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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

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

NCT ID

NCT00213863

First Posted

September 13, 2005

Last Updated

June 28, 2012

Sponsor

University Hospital, Strasbourg, France

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

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

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Debry, MD

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

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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