Skip to main content
OpenTrials
Completed

NCT Number: NCT00576134

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Swallowing Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Strasbourg, 67098, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age more than 18
  • Swallowing troubles

Exclusion criteria

  • Pregnant women
  • Contraindications to general anesthesia

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Respiratory evaluation

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

Secondary outcomes

  1. Nasofibroscopy

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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 18, 2007
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.