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

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT00576134
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 66
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Swallowing Disorders; Dysphagia; Laryngeal Neoplasms	Device: Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Outcome Measures

Primary Outcome Measures

1. Respiratory evaluation [Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36]

Secondary Outcome Measures

1. Nasofibroscopy [Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Age more than 18

• Swallowing troubles

Exclusion criteria:

• Pregnant women

• Contraindications to general anesthesia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière	Strasbourg		France	67098

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Christian DEBRY, MD, Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT00576134
• Other Study ID Numbers: 3866
• First Posted: Dec 18, 2007
• Last Update Posted: Jan 26, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by University Hospital, Strasbourg, France: Larynx, tracheotomy, titanium beads
• Additional relevant MeSH terms: Laryngeal Neoplasms; Deglutition Disorders

Study Results

No Results Posted as of Jan 26, 2015