Establishment of an Artificial Larynx After Total Laryngectomy (LA)

June 28, 2012 updated by: University Hospital, Strasbourg, France
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

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, 67091 Strasbourg Cedex
        • Recruiting
        • Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
        • Principal Investigator:
          • Christian DEBRY, PU-PH
        • Sub-Investigator:
          • Patrick HEMAR, PH
        • Sub-Investigator:
          • Philippe SCHULTZ, PU-PH

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:

  • Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy

Exclusion Criteria:

  • Less than 18 years
  • Contraindications to general anesthesia
  • Any situation considered by the physician operator as an exclusion
  • Pregnant women
  • Lactating women
  • Subglottic or basi-lingual tumor extension more than 1 cm
  • Prior radiotherapy
  • Severe coagulation 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
Measure Description
Time Frame
Evaluation of the restoration of respiratory functions
Time Frame: one year

4 items will be used:

  • 0: no dyspnea
  • 1: moderate dyspnea
  • 2: significant dyspnea
  • 3: major dyspnea
one year
Evaluation of the restoration of the ability to swallow by nasofibroscopy
Time Frame: one year

3 items will be used:

  • 1: no aspiration
  • 2: moderate aspiration
  • 3: massive aspiration
one year

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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

October 1, 2011

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 17, 2011

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

  • 4493

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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