Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

NCT ID: NCT00213863

Last Updated: 2012-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Vocal Cord Paralysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Debry, MD

Role: PRINCIPAL_INVESTIGATOR

Hopitaux Universitaires de Strasbourg

Locations

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

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christian Debry, MD

Role: CONTACT

Facility Contacts

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Christian Debry, MD

Role: primary

33.3.88.12.76.45

Other Identifiers

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3097

Identifier Type: -

Identifier Source: org_study_id

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