Total LaryngectomyNCT01948219
ENTegral Artificial Larynx Clinical Trial
A study testing ENTegral Artificial Larynx implant in people with Total Laryngectomy, run by ProTiP Medical at 3 sites in 2 countries.
Trial summary
The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Laryngectomy
- What is being tested?
- ENTegral Artificial Larynx implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2014to 30 Jun 2016
- 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
- Age more than or equal to 18 years old
- Is indicated for total laryngectomy (first intention)
- Must be able to comply with study requirements
- Must be able to understand and be willing to provide written informed consent
Who cannot join
- Any condition that precludes the implantation of the ENTegral AL
- Existing coagulation disorder
- Contraindication for general anesthesia
- Tumoral extension outside of the larynx invading through extra-laryngeal structures
- Previous radiotherapy
- Life-expectancy < 12 months
- Be pregnant of breastfeeding or intention to becoming pregnant during study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy
The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.
- Conditions
- Total Laryngectomy
- Being tested
- ENTegral Artificial Larynx implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENTegral Artificial Larynx implantDevice
| Study group | Role | What they receive |
|---|---|---|
| ENTegral Artificial Larynx implant | Experimental | ENTegral Artificial Larynx implantation Receives: Device: ENTegral Artificial Larynx implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of device implant procedure
Number of patients with adverse event associated with device implantation procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startOct 2014
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total LaryngectomyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProTiP Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948219
- Sponsor's protocol ID
- LA-01-PEC-1
- Status last verified
- Apr 2018
- First submitted
- 16 Sep 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy
- ClinicalTrials.gov ID
- NCT01948219
- Acronym / sponsor ID
- LA-01-PEC-1
- Conditions
- Total Laryngectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ProTiP MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 23 Sep 2013 (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.
The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENTegral Artificial Larynx implant | Experimental | Device: ENTegral Artificial Larynx implantENTegral Artificial Larynx implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than or equal to 18 years old
- Is indicated for total laryngectomy (first intention)
- Must be able to comply with study requirements
- Must be able to understand and be willing to provide written informed consent
Key exclusion criteria (7 listed)
- Any condition that precludes the implantation of the ENTegral AL
- Existing coagulation disorder
- Contraindication for general anesthesia
- Tumoral extension outside of the larynx invading through extra-laryngeal structures
- Previous radiotherapy
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 |
|---|---|---|
| ENTegral Artificial Larynx implant | Device | ENTegral Artificial Larynx implant |
Primary outcome
Feasibility of device implant procedure
Time frame: 1 year
Number of patients with adverse event associated with device implantation procedure
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENTegral Artificial Larynx implant in people with Total Laryngectomy, run by ProTiP Medical at 3 sites in 2 countries.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. 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?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Feasibility of device implant procedure (time frame: 1 year). 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 5 Apr 2018.