Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
NCT ID: NCT00213863
Last Updated: 2012-07-02
Study Results
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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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2010-12-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women
* Local carcinoma excluding radiotherapeutic or surgical control
* Bad general condition
* Contraindication to general anesthesia
* Non-controlled diabetes
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3097
Identifier Type: -
Identifier Source: org_study_id
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