Establishment of an Artificial Larynx After Total Laryngectomy (LA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
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
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, see Learn About Clinical Studies.

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 September 15, 2014