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

University Hospital, Strasbourg, France

Status and phase: Completed; Phase 1

Conditions: Dysphagia; Swallowing Disorders; Laryngeal Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00576134

3866

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age more than 18
• Swallowing troubles

Exclusion criteria

• Pregnant women
• Contraindications to general anesthesia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)