NCT00576134

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

Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Swallowing Disorders
• Dysphagia
• Laryngeal Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2007-12-18
• Last updated: 2025-12-22

Locations

1 site across 1 country: France