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

October 20, 2011
June 28, 2012
October 2011
October 2013   (final data collection date for primary outcome measure)
  • 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
  • Evaluation of the restoration of respiratory functions

    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

    3 items will be used:

    • 1: no aspiration
    • 2: moderate aspiration
    • 3: massive aspiration
Complete list of historical versions of study NCT01474005 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Establishment of an Artificial Larynx After Total Laryngectomy
Establishment of an Artificial Larynx After Total Laryngectomy

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinomatous Disease
Device: PROTIP MEDICAL ( Artificial larynx prosthesis)
establishment of an artificial larynx prosthesis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Christian DEBRY, PU-PH 03.88.12.76.45 ext 33 christian.debry@chru-strasbourg.fr
France
 
NCT01474005
4493
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Not Provided
University Hospital, Strasbourg, France
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP