AspirationNCT02437513
NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
An observational study of Aspiration and Laryngeal Cancer, run by ProTiP Medical.
Trial summary
Laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy (surgery or radio/chemotherapy). Laryngeal dysfunction is associated with higher incidences of aspiration and respiratory tract complications such as aspiration pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration, Laryngeal Cancer
- What is being tested?
- NewBreez
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Nov 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Recruitment of patients will primarily be from the department of Ear, Nose and Throat at the hospitals participating in the study. Secondary recruitment could also include associated clinics that treat patients with laryngeal dysfunction and aspiration, such as swallowing therapy clinics, speech language therapy clinics, and linguistics clinics.
Who may be able to join
- History of head and neck cancer
- Chronic aspiration
- Currently has a tracheostomy
- Patient is able to independently maintain their tracheostomy and cannula apparatus
- Patient meets the CE Mark indications and are not contraindicated for a NewBreez procedure.
- Anatomically compatible with the available sizes of NewBreez®
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- 18 years of age or older
- Sufficient cognitive function to comply with the study and follow-up requirements
- Patient gives voluntary signed informed consent
Who cannot join
- Recurrent or present cancer in the previous 12 months
- Absent cough reflex
- Severely disrupted swallowing function e.g. severe neurological deficit, absent swallowing reflex, severe fixation of the larynx due to scarring with absent elevation of the larynx
- Upper esophageal sphincter not functional e.g. remains closed
- Cor Pulmonale / Pulmonary Heart Disease, or current lung infection
- Mouth opening less than 3.5cm
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- Neck extension severely restricted hindering implantation of the device
- Contraindication to general anesthesia
- Severe hyperostosis (spondylophytes) of the cervical vertebrae causing dysphagia
- Severe (radiogenic) edema or damage of the mucosa of the upper aerodigestive tract
About this study
Laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy (surgery or radio/chemotherapy). Laryngeal dysfunction is associated with higher incidences of aspiration and respiratory tract complications such as aspiration pneumonia. Current standard of care treatment to reduce the consequences of aspiration is often a tracheostomy which has its own risks and complications. The proposed study aims to describe the performance of a new CE marked medical implant, the NewBreez, in protecting the patient's airways from aspiration.
Read the detailed description
Aspiration is associated with respiratory tract infections, reduced quality of life and increased mortality in patients. For chronic or unresolved aspiration, patients are often given a tracheostomy for safer breathing and greater protection of the airways from aspirated material. However tracheostomies are associated with risks and complications and do not give a 100% guarantee of aspiration protection to the patient. They also impact the quality of life in a negative way for many patients. The current study will evaluate the performance of a new intralaryngeal device for airway protection in a small group of patients who have chronic aspiration. The study will look at the overall performance of this device in preventing aspiration in this specific group of patients as well as determine any unforeseen risks of using this device in the identified group of patients. The outcomes will form the basis of future studies with larger groups of patients.
- Conditions
- Aspiration, Laryngeal Cancer
- Being tested
- NewBreez
- Keywords
- Dysphagia, Aspiration, Laryngeal cancer
- Medical subject headings
- Laryngeal Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NewBreezDevice
Also called Intralaryngeal Prosthesis
Intralaryngeal prosthesis to protect the airways
| Study group | Role | What they receive |
|---|---|---|
| NewBreez | The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician.
Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires. Receives: Device: NewBreez |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Per Patient of Number and Severity of Aspiration Events
In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12
Measured: 12 weeks
Secondary outcomes (3)
Number of Reported Adverse Events
Analysis of the reported system or procedure related adverse events using standard AE reporting form
Measured: at device implantation
Number of Reported Adverse Events
Analysis of the the rate and severity of reported system or procedure related adverse events as a measure of safety of the device in this patient population over a 12 week period
Measured: 2 weeks
Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score
In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score:
0 = None
- = Mild, some difficulty
- = Moderate Difficulty but can continue
- = Severe difficulty, cannot continue
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionNov 2016
Why it stopped: Recruitment rates too low to continue with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AspirationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProTiP Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ursula Schroeder, Dr. med., Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437513
- Sponsor's protocol ID
- NB for HNC
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2015
- Last updated
- 24 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
- ClinicalTrials.gov ID
- NCT02437513
- Acronym / sponsor ID
- NB for HNC
- Conditions
- Aspiration, Laryngeal Cancer
- Keywords
- Dysphagia, Aspiration, Laryngeal cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment rates too low to continue with the study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ProTiP MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Posted 24 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy (surgery or radio/chemotherapy). Laryngeal dysfunction is associated with higher incidences of aspiration and respiratory tract complications such as aspiration pneumonia. Current standard of care treatment to reduce the consequences of aspiration is often a tracheostomy which has its own risks and complications. The proposed study aims to describe the performance of a new CE marked medical implant, the NewBreez, in protecting the patient's airways from aspiration.
Detailed description
Aspiration is associated with respiratory tract infections, reduced quality of life and increased mortality in patients. For chronic or unresolved aspiration, patients are often given a tracheostomy for safer breathing and greater protection of the airways from aspirated material. However tracheostomies are associated with risks and complications and do not give a 100% guarantee of aspiration protection to the patient. They also impact the quality of life in a negative way for many patients. The current study will evaluate the performance of a new intralaryngeal device for airway protection in a small group of patients who have chronic aspiration. The study will look at the overall performance of this device in preventing aspiration in this specific group of patients as well as determine any unforeseen risks of using this device in the identified group of patients. The outcomes will form the basis of future studies with larger groups of patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NewBreez | – | Device: NewBreezThe study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician. Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of patients will primarily be from the department of Ear, Nose and Throat at the hospitals participating in the study. Secondary recruitment could also include associated clinics that treat patients with laryngeal dysfunction and aspiration, such as swallowing therapy clinics, speech language therapy clinics, and linguistics clinics.
Key inclusion criteria (9 listed)
- History of head and neck cancer
- Chronic aspiration
- Currently has a tracheostomy
- Patient is able to independently maintain their tracheostomy and cannula apparatus
- Patient meets the CE Mark indications and are not contraindicated for a NewBreez procedure.
Key exclusion criteria (10 listed)
- Recurrent or present cancer in the previous 12 months
- Absent cough reflex
- Severely disrupted swallowing function e.g. severe neurological deficit, absent swallowing reflex, severe fixation of the larynx due to scarring with absent elevation of the larynx
- Upper esophageal sphincter not functional e.g. remains closed
- Cor Pulmonale / Pulmonary Heart Disease, or current lung infection
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 |
|---|---|---|
| NewBreezAlso: Intralaryngeal ProsthesisIntralaryngeal prosthesis to protect the airways | Device | NewBreez |
Primary outcome
Change From Baseline Per Patient of Number and Severity of Aspiration Events
Time frame: 12 weeks
In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12
3 secondary outcomes
Number of Reported Adverse Events
Time frame: at device implantation
Number of Reported Adverse Events
Time frame: 2 weeks
Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score
Time frame: 1 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Ursula Schroeder, Dr. med. principal investigator
University of Luebeck
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration and Laryngeal Cancer, run by ProTiP Medical.
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 9 inclusion and 10 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline Per Patient of Number and Severity of Aspiration Events (time frame: 12 weeks). 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 24 Aug 2017.