Aspiration, Laryngeal Cancer
Conditions
Keywords
Dysphagia, Aspiration, Laryngeal cancer
Brief 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. 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.
Interventions
DEVICENewBreez
Intralaryngeal prosthesis to protect the airways
Sponsors
ProTiP Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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® * 18 years of age or older * Sufficient cognitive function to comply with the study and follow-up requirements * Patient gives voluntary signed informed consent
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Per Patient of Number and Severity of Aspiration Events | 12 weeks | In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Reported Adverse Events | at device implantation | Analysis of the reported system or procedure related adverse events using standard AE reporting form |
| Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score | 1 weeks | In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score: 0 = None 1. = Mild, some difficulty 2. = Moderate Difficulty but can continue 3. = Severe difficulty, cannot continue |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reported Device Migration in the Larynx Post Implant | 1 weeks | In patient change from baseline position of the device in the larynx of each patient assessed by endoscopy and/or other clinically appropriate methods (CT or video fluoroscopy) and recorded in migration direction and distance (cm) |
| Change From Baseline of Quality of Life (QoL) Score | 12 weeks | In patient QoL assessed at baseline and at 12 weeks using German standard QoL clinical questionnaire specifically for patients with swallowing dysfunction |
| Reported Subjective Rating of Comfort of the Device in the Larynx | 12 weeks | In patient subjective measure (repeated) of pain score (1-10) and comfort level (questionnaire) at weeks 1,4,8,12 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
NewBreez: Intralaryngeal prosthesis to protect the airways | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | NewBreez |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment Germany | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
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
Time frame: 12 weeks
Population: First patient: Device was explanted within 48 hours after implantation - no Data could be collected Second Patient: Due to patient's non-compliance no data could be collected.Device was explanted within two weeks after implantation.
Secondary
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 1. = Mild, some difficulty 2. = Moderate Difficulty but can continue 3. = Severe difficulty, cannot continue
Time frame: 1 weeks
Population: Second enrolled patient did not reach the first data point, subj. was explanted prior first measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NewBreez | Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score | 1 participants |
Secondary
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
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NewBreez | Number of Reported Adverse Events | 2 AE reported |
Secondary
Number of Reported Adverse Events
Analysis of the reported system or procedure related adverse events using standard AE reporting form
Time frame: at device implantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NewBreez | Number of Reported Adverse Events | 0 adverse events |
Other Pre-specified
Change From Baseline of Quality of Life (QoL) Score
In patient QoL assessed at baseline and at 12 weeks using German standard QoL clinical questionnaire specifically for patients with swallowing dysfunction
Time frame: 12 weeks
Other Pre-specified
Number of Participants With Reported Device Migration in the Larynx Post Implant
In patient change from baseline position of the device in the larynx of each patient assessed by endoscopy and/or other clinically appropriate methods (CT or video fluoroscopy) and recorded in migration direction and distance (cm)
Time frame: 1 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NewBreez | Number of Participants With Reported Device Migration in the Larynx Post Implant | 1 participants |
Other Pre-specified
Reported Subjective Rating of Comfort of the Device in the Larynx
In patient subjective measure (repeated) of pain score (1-10) and comfort level (questionnaire) at weeks 1,4,8,12
Time frame: 12 weeks