Status:
UNKNOWN
Establishment of an Artificial Larynx After Total Laryngectomy
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Carcinomatous Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.
Eligibility Criteria
Inclusion
- Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01474005
Start Date
October 1 2011
End Date
October 1 2013
Last Update
July 2 2012
Active Locations (1)
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1
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
Strasbourg, France, 67091 Strasbourg Cedex