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

Phase 1

Completed

• Conditions: Dysphagia; Swallowing Disorders; Laryngeal Neoplasms

• Registration Number: NCT00576134
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Study Start: 2008-02
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Respiratory evaluation	Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36

Secondary Outcome Measures

Name	Time	Method
Nasofibroscopy	Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36

Trial Locations

Locations (1)

Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière; 🇫🇷 Strasbourg, France