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NCT00576134 Clinical Trial

The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement

Dysphagia Clinical Trial

Official title:
Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00576134
Other study ID # 3866
Secondary ID
Status Completed
Phase Phase 1
First received December 12, 2007
Last updated January 22, 2015
Start date February 2008
Est. completion date August 2013

Study information
Verified date January 2015
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in order to allow tracheotomy closing (when applicable) and / or to allow restoration of god swallowing capacity. The secondary objective is to study the concept of a special valves system for the development of an artificial larynx

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Age more than 18

- Swallowing troubles

Exclusion criteria:

- Pregnant women

- Contraindications to general anesthesia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing
An artificial Larynx composed of a tracheobronxane ® Dumon ST prosthesis and a valves system will be implant under general anesthesia by endoscopy. The 3 first patients will be patients with tracheotomy, in order to allow breathing through this tracheotomy in case of valves dysfunction.

Locations
Country Name City State
France Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory evaluation Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36 Yes
Secondary Nasofibroscopy Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36 No
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