ClinicalTrials.gov
ClinicalTrials.gov Menu

Establishment of an Artificial Larynx After Total Laryngectomy (LA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01474005
Recruitment Status : Unknown
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : November 17, 2011
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.

Condition or disease Intervention/treatment Phase
Carcinomatous Disease Device: PROTIP MEDICAL ( Artificial larynx prosthesis) Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Establishment of an Artificial Larynx After Total Laryngectomy
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013
Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Device: PROTIP MEDICAL ( Artificial larynx prosthesis)
    establishment of an artificial larynx prosthesis

Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474005


Contacts
Contact: Christian DEBRY, PU-PH 03.88.12.76.45 ext 33 christian.debry@chru-strasbourg.fr

Locations
France
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière Recruiting
Strasbourg, France, 67091 Strasbourg Cedex
Principal Investigator: Christian DEBRY, PU-PH         
Sub-Investigator: Patrick HEMAR, PH         
Sub-Investigator: Philippe SCHULTZ, PU-PH         
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01474005     History of Changes
Other Study ID Numbers: 4493
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by University Hospital, Strasbourg, France:
laryngectomy
artificial larynx
breathing
swallowing
upper airway