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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Swallowing Disorders Dysphagia Laryngeal Neoplasms

Keywords

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Larynx, tracheotomy, titanium beads

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age more than 18
* Swallowing troubles

Exclusion Criteria

* Pregnant women
* Contraindications to general anesthesia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian DEBRY, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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

Strasbourg, , France

Site Status

Countries

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France

References

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Chambres O, Schultz P, Debry C. The Larynxane ST intralaryngeal endoprosthesis for laryngotracheal pathologies. J Laryngol Otol. 2006 Nov;120(11):942-8. doi: 10.1017/S0022215106000466. Epub 2006 May 4.

Reference Type RESULT

PMID: 16672085 (View on PubMed)

Debry C, Charles X, Frenot M, Gentine A. Intra-laryngeal endoprosthesis: an alternative therapeutic approach to surgical procedures of laryngeal exclusion. J Laryngol Otol. 2000 Oct;114(10):760-4. doi: 10.1258/0022215001904095.