Establishment of an Artificial Larynx After Total Laryngectomy (LA)

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01474005
First received: October 20, 2011
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.


Condition Intervention
Carcinomatous Disease
Device: PROTIP MEDICAL ( Artificial larynx prosthesis)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Establishment of an Artificial Larynx After Total Laryngectomy

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Evaluation of the restoration of respiratory functions [ Time Frame: one year ] [ Designated as safety issue: No ]

    4 items will be used:

    • 0: no dyspnea
    • 1: moderate dyspnea
    • 2: significant dyspnea
    • 3: major dyspnea

  • Evaluation of the restoration of the ability to swallow by nasofibroscopy [ Time Frame: one year ] [ Designated as safety issue: No ]

    3 items will be used:

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


Estimated Enrollment: 5
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PROTIP MEDICAL ( Artificial larynx prosthesis)
    establishment of an artificial larynx prosthesis
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01474005     History of Changes
Other Study ID Numbers: 4493
Study First Received: October 20, 2011
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on April 16, 2014