NCT00576134

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

5.5 years

First QC Date

December 12, 2007

Last Update Submit

December 15, 2025

Conditions

Swallowing DisordersDysphagiaLaryngeal Neoplasms

Keywords

Larynx, tracheotomy, titanium beads

Outcome Measures

Primary Outcomes (1)

  • Respiratory evaluation

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

Secondary Outcomes (1)

  • Nasofibroscopy

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

Interventions

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

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18
  • Swallowing troubles

You may not qualify if:

  • Pregnant women
  • Contraindications to general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Strasbourg, 67098, France

Location

Related Publications (2)

  • 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.

    PMID: 16672085RESULT

  • 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.

    PMID: 11127145RESULT

MeSH Terms

Conditions

Deglutition DisordersLaryngeal NeoplasmsLaryngeal Diseases

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract DiseasesRespiratory Tract Neoplasms

Study Officials

  • Christian DEBRY, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 18, 2007

Study Start

February 1, 2008

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

FR(1)