Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

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

The benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. The functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

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

Study Locations

France
- - Strasbourg, France, 67082
    - Recruiting
    - Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
    - Contact:
      
      Christian DEBRY, MD
      
      Phone Number: 33.3.88.12.76.44
      
      Email: christian.debry@chru-strasbourg.fr
    - Sub-Investigator:
      
      Patrick HEMAR, MD
    - Sub-Investigator:
      
      Philippe SCHULTZ, MD
    - Principal Investigator:
      
      Christian DEBRY, MD

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

Genders Eligible for Study

All

Description

Inclusion criteria:

age more than 18
total laryngectomy or pharyngo-larynctomy

Exclusion criteria:

pregnant women-age less than 18
major pulmonary bronchitis
major neurological disorders

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
Clinical measures concerning peri and intra prosthetic leakage Time Frame: days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36	days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36

Secondary Outcome Measures

Outcome Measure	Time Frame
Phonology's measures Time Frame: months 1, 3,12	months 1, 3,12

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

Collaborators

OseoAnvar

Réseau National des Technologies de Santé

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, 2007

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

November 6, 2006

First Submitted That Met QC Criteria