Trial Outcomes & Findings for NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration (NCT NCT02437513)
NCT ID: NCT02437513
Last Updated: 2017-08-24
Results Overview
In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12
TERMINATED
2 participants
12 weeks
2017-08-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
Baseline characteristics by cohort
| Measure |
NewBreez
n=2 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at device implantationAnalysis of the reported system or procedure related adverse events using standard AE reporting form
Outcome measures
| Measure |
NewBreez
n=2 Participants
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
|
|---|---|
|
Number of Reported Adverse Events
|
0 adverse events
|
SECONDARY outcome
Timeframe: 2 weeksAnalysis 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
Outcome measures
| Measure |
NewBreez
n=2 Participants
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
|
|---|---|
|
Number of Reported Adverse Events
|
2 AE reported
|
SECONDARY outcome
Timeframe: 1 weeksPopulation: Second enrolled patient did not reach the first data point, subj. was explanted prior first measurement.
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
Outcome measures
| Measure |
NewBreez
n=1 Participants
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
|
|---|---|
|
Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score
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1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weeksIn 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)
Outcome measures
| Measure |
NewBreez
n=2 Participants
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
|
|---|---|
|
Number of Participants With Reported Device Migration in the Larynx Post Implant
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksIn patient QoL assessed at baseline and at 12 weeks using German standard QoL clinical questionnaire specifically for patients with swallowing dysfunction
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksIn patient subjective measure (repeated) of pain score (1-10) and comfort level (questionnaire) at weeks 1,4,8,12
Outcome measures
Outcome data not reported
Adverse Events
NewBreez
Serious adverse events
| Measure |
NewBreez
n=2 participants at risk
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
|
|---|---|
|
Product Issues
aspiration
|
50.0%
1/2 • Number of events 1 • subject 1: 24 hours after receiving the NewBreez implant subject 2: 11 days after receiving the NewBreez implant
|
Other adverse events
| Measure |
NewBreez
n=2 participants at risk
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
|
|---|---|
|
Product Issues
Device migration
|
50.0%
1/2 • Number of events 1 • subject 1: 24 hours after receiving the NewBreez implant subject 2: 11 days after receiving the NewBreez implant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place