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

History of Changes

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:

establishment of an artificial larynx prosthesis

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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


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 30, 2016

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