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

University Hospital, Strasbourg, France10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Swallowing Disorders Dysphagia Laryngeal Neoplasms

Interventions

Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Age more than 18 * Swallowing troubles Exclusion criteria: * Pregnant women * Contraindications to general anesthesia

Locations (1)

Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière

Strasbourg, France

Outcomes

Primary Outcomes

Respiratory evaluation

Time frame: Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36

Secondary Outcomes

Nasofibroscopy

Time frame: Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36

Data from ClinicalTrials.gov

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