Swallowing DisordersPhase 1NCT00576134
The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement
A Phase 1 study testing Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing in people with Swallowing Disorders and Dysphagia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Disorders, Dysphagia, Laryngeal Neoplasms
- What is being tested?
- Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18
- Swallowing troubles
Who cannot join
- Pregnant women
- Contraindications to general anesthesia
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
Strasbourg, 67098
About this study
Official title: Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles
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
- Conditions
- Swallowing Disorders, Dysphagia, Laryngeal Neoplasms
- Being tested
- Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing
- Keywords
- Larynx, tracheotomy, titanium beads
- Medical subject headings
- Deglutition Disorders, Laryngeal Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory evaluation
Measured: Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36
Secondary outcomes (1)
Nasofibroscopy
Measured: Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Swallowing DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian DEBRY, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576134
- Sponsor's protocol ID
- 3866
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2007
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16672085Debry 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.
PubMed 11127145
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles
- ClinicalTrials.gov ID
- NCT00576134
- Acronym / sponsor ID
- 3866
- Conditions
- Swallowing Disorders, Dysphagia, Laryngeal Neoplasms
- Keywords
- Larynx, tracheotomy, titanium beads
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18
- Swallowing troubles
Key exclusion criteria (2 listed)
- Pregnant women
- Contraindications to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closingAn 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. | Device | – |
Primary outcome
Respiratory evaluation
Time frame: Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36
1 secondary outcome
Nasofibroscopy
Time frame: Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 16672085Chambres 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.
- Results publication: PubMed 11127145Debry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian DEBRY, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing in people with Swallowing Disorders and Dysphagia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory evaluation (time frame: Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00576134, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.