Aspiration PneumoniaNCT03325725
Intra-laryngeal Implant for Treatment of Chronic Aspirations
A study testing NewBreez LD intra-laryngeal implant in people with Aspiration Pneumonia and Tracheostomy Complication, run by ProTiP Medical at 2 sites in France.
Trial summary
This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonia, Tracheostomy Complication
- What is being tested?
- NewBreez LD intra-laryngeal implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Jan 2018to 9 Jan 2018
- 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
- Swallowing disorders characterized by chronic aspirations;
- Tracheotomy performed, inter alia, in the management of swallowing disorders;
- Aged over 18;
- Willing and able to comply with the requirements of the study;
- Informed consent signed;
- Affiliated patient or beneficiary of the social security system.
Who cannot join
- Do not implant in patients with incomplete cricoid cartilage (surgery or other);
- Do not implant in patients with tracheotomy performed by cricothyroidectomy or between cricoid cartilage and the 1st tracheal ring;
- Do not implant in patients with tracheal lumen in the 1st tracheal ring, the lateral and anteroposterior diameters of which are less than 11 mm;
- Do not implant in patients with tight trismus;
- Do not implant in subjects less than 18 years of age;
- Do not implant in patients with bleeding disorders;
- Do not implant in patients contraindicated to general anesthesia.
Trial locations and contacts
2 sites in 1 country.
About this study
This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia.
Read the detailed description
Patients suffering from swallowing disorders characterized by chronic aspirations (repeated episodes of aspirations defined as penetration of material - liquids, food, saliva, into the respiratory system due to a malfunctioning of the swallowing mechanism) are subject to pathologies and pulmonary insufficiencies. The risks of aspiration pneumonia or suffocation are significantly greater if the patient is not able to expectorate and thus engages the vital prognosis. There are several methods to treat chronic aspirations: the least invasive methods involve adopting postures and/or positions of the body during swallowing and adapting food textures; when these treatments are insufficient there is the need to recur to more advanced ones to protect the airways and keep the patient on a sufficient nutrition.
For these severe cases, heavier surgical methods can be also considered. These methods lead to important anatomical changes, with a variable degree of reversibility, up to irreversibility (eg total laryngectomy). Among surgical methods, there is also an implant of a tracheotomy cuffed cannula that allows patient to breathe through a hole in the trachea. The efficacy of this solution is highly controversial as reported by numerous studies and several adverse effects are reported on the tracheal duct.
Due to the interest of a prosthetic treatment and the disadvantages of the current methods and devices, PROTiP Medical has developed a closed intra-laryngeal implant: NewBreez LD. This device is innovative because its geometry has been optimized to conform totally to the anatomy of the larynx with the aim to ensure a sealing against saliva, liquids and food aspirations.
- Conditions
- Aspiration Pneumonia, Tracheostomy Complication
- Being tested
- NewBreez LD intra-laryngeal implant
- Keywords
- severe aspiration
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NewBreez LD intra-laryngeal implantDevice
NewBreez LD intra-laryngeal implantation
| Study group | Role | What they receive |
|---|---|---|
| NewBreez LD Intra-laryngeal implant | Experimental | Not described Receives: Device: NewBreez LD intra-laryngeal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealing of the NewBreez LD: Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)
Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start9 Jan 2018
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
Why it stopped: The Competent Authority did not give the authorization to start the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration PneumoniaStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProTiP Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Debry, Pr., Principal investigator, CHU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325725
- Sponsor's protocol ID
- NB_LD
- Status last verified
- Jan 2018
- First submitted
- 17 Oct 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-laryngeal Implant for Treatment of Chronic Aspirations
- ClinicalTrials.gov ID
- NCT03325725
- Acronym / sponsor ID
- NB_LD
- Conditions
- Aspiration Pneumonia, Tracheostomy Complication
- Keywords
- severe aspiration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Competent Authority did not give the authorization to start the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProTiP MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 30 Oct 2017 (actual)
- 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 evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia.
Detailed description
Patients suffering from swallowing disorders characterized by chronic aspirations (repeated episodes of aspirations defined as penetration of material - liquids, food, saliva, into the respiratory system due to a malfunctioning of the swallowing mechanism) are subject to pathologies and pulmonary insufficiencies. The risks of aspiration pneumonia or suffocation are significantly greater if the patient is not able to expectorate and thus engages the vital prognosis. There are several methods to treat chronic aspirations: the least invasive methods involve adopting postures and/or positions of the body during swallowing and adapting food textures; when these treatments are insufficient there is the need to recur to more advanced ones to protect the airways and keep the patient on a sufficient nutrition.
For these severe cases, heavier surgical methods can be also considered. These methods lead to important anatomical changes, with a variable degree of reversibility, up to irreversibility (eg total laryngectomy). Among surgical methods, there is also an implant of a tracheotomy cuffed cannula that allows patient to breathe through a hole in the trachea. The efficacy of this solution is highly controversial as reported by numerous studies and several adverse effects are reported on the tracheal duct.
Due to the interest of a prosthetic treatment and the disadvantages of the current methods and devices, PROTiP Medical has developed a closed intra-laryngeal implant: NewBreez LD. This device is innovative because its geometry has been optimized to conform totally to the anatomy of the larynx with the aim to ensure a sealing against saliva, liquids and food aspirations.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NewBreez LD Intra-laryngeal implant | Experimental | Device: NewBreez LD intra-laryngeal implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Swallowing disorders characterized by chronic aspirations;
- Tracheotomy performed, inter alia, in the management of swallowing disorders;
- Aged over 18;
- Willing and able to comply with the requirements of the study;
- Informed consent signed;
Key exclusion criteria (7 listed)
- Do not implant in patients with incomplete cricoid cartilage (surgery or other);
- Do not implant in patients with tracheotomy performed by cricothyroidectomy or between cricoid cartilage and the 1st tracheal ring;
- Do not implant in patients with tracheal lumen in the 1st tracheal ring, the lateral and anteroposterior diameters of which are less than 11 mm;
- Do not implant in patients with tight trismus;
- Do not implant in subjects less than 18 years of age;
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 |
|---|---|---|
| NewBreez LD intra-laryngeal implantNewBreez LD intra-laryngeal implantation | Device | NewBreez LD Intra-laryngeal implant |
Primary outcome
Sealing of the NewBreez LD: Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)
Time frame: 7 days
Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
Christian Debry, Pr. principal investigator
CHU Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NewBreez LD intra-laryngeal implant in people with Aspiration Pneumonia and Tracheostomy Complication, run by ProTiP Medical at 2 sites 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 6 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: withdrawn, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sealing of the NewBreez LD: Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS) (time frame: 7 days). 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 12 Jan 2018.