Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

June 28, 2012 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France
        • Recruiting
        • Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
        • Sub-Investigator:
          • Philippe SCHULTZ, MD
        • Principal Investigator:
          • Christian DEBRY, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nasofibroscopy
Time Frame: 8 days and 3 months after surgery
8 days and 3 months after surgery
Voice control and recording
Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
All types of complication
Time Frame: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Christian DEBRY, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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