Carcinomatous DiseaseLANCT01474005
Establishment of an Artificial Larynx After Total Laryngectomy
A study testing PROTIP MEDICAL ( Artificial larynx prosthesis) in people with Carcinomatous Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinomatous Disease
- What is being tested?
- PROTIP MEDICAL ( Artificial larynx prosthesis)
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Oct 2013
- Phase
- Interventional
- 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
- Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy
Who cannot join
- Less than 18 years
- Contraindications to general anesthesia
- Any situation considered by the physician operator as an exclusion
- Pregnant women
- Lactating women
- Subglottic or basi-lingual tumor extension more than 1 cm
- Prior radiotherapy
- Severe coagulation disorders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
Strasbourg, 67091 Strasbourg Cedex
Christian DEBRY, PU-PH
Patrick HEMAR, PH
About this study
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.
- Conditions
- Carcinomatous Disease
- Being tested
- PROTIP MEDICAL ( Artificial larynx prosthesis)
- Keywords
- laryngectomy, artificial larynx, breathing, swallowing, upper airway
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTIP MEDICAL ( Artificial larynx prosthesis)Device
establishment of an artificial larynx prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the restoration of respiratory functions
4 items will be used:
- 0: no dyspnea
- 1: moderate dyspnea
- 2: significant dyspnea
- 3: major dyspnea
Measured: one year
Evaluation of the restoration of the ability to swallow by nasofibroscopy
3 items will be used:
- 1: no aspiration
- 2: moderate aspiration
- 3: massive aspiration
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinomatous DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474005
- Sponsor's protocol ID
- 4493
- Acronym
- LA
- Status last verified
- Jun 2012
- First submitted
- 20 Oct 2011
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of an Artificial Larynx After Total Laryngectomy
- ClinicalTrials.gov ID
- NCT01474005
- Acronym / sponsor ID
- LA / 4493
- Conditions
- Carcinomatous Disease
- Keywords
- laryngectomy, artificial larynx, breathing, swallowing, upper airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 17 Nov 2011 (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.
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.
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 (1 listed)
- Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy
Key exclusion criteria (8 listed)
- Less than 18 years
- Contraindications to general anesthesia
- Any situation considered by the physician operator as an exclusion
- Pregnant women
- Lactating women
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 |
|---|---|---|
| PROTIP MEDICAL ( Artificial larynx prosthesis)establishment of an artificial larynx prosthesis | Device | – |
Primary outcome
Evaluation of the restoration of respiratory functions
Time frame: one year
4 items will be used: * 0: no dyspnea * 1: moderate dyspnea * 2: significant dyspnea * 3: major dyspnea
Evaluation of the restoration of the ability to swallow by nasofibroscopy
Time frame: one year
3 items will be used: * 1: no aspiration * 2: moderate aspiration * 3: massive aspiration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROTIP MEDICAL ( Artificial larynx prosthesis) in people with Carcinomatous Disease, 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Jul 2012. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian DEBRY, PU-PH (03.88.12.76.45 ext. 33, christian.debry@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the restoration of respiratory functions (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2012; AzTrials last refreshed its copy on 7 Nov 2026.