NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration

• Sponsor: ProTiP Medical (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02437513
• Collaborator: (none)
• Enrollment: 2
• Duration (Months): 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aspiration; Laryngeal Cancer	Device: NewBreez

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

• Study Type: Observational
• Actual Enrollment: 2 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

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.

Device: NewBreez; Intralaryngeal prosthesis to protect the airways; Other Names: Intralaryngeal Prosthesis

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Number of Reported Adverse Events [at device implantation]

   Analysis of the reported system or procedure related adverse events using standard AE reporting form

2. Number of Reported Adverse Events [2 weeks]

   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

3. 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 = Mild, some difficulty = Moderate Difficulty but can continue = Severe difficulty, cannot continue

Other Outcome Measures

1. 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)

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ProTiP Medical

Investigators

• Principal Investigator: Ursula Schroeder, Dr. med., University of Luebeck

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ProTiP Medical
• ClinicalTrials.gov Identifier: NCT02437513
• Other Study ID Numbers: NB for HNC
• First Posted: May 7, 2015
• Last Update Posted: Aug 24, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by ProTiP Medical: Dysphagia; Aspiration; Laryngeal cancer
• Additional relevant MeSH terms: Head and Neck Neoplasms; Laryngeal Neoplasms

Study Results

Participant Flow

Arm/Group Title	NewBreez
Arm/Group Description	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
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	NewBreez
Arm/Group Description	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 Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Region of Enrollment (participants) [Number]
Germany	2 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Per Patient of Number and Severity of Aspiration Events
Description	In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	NewBreez
Arm/Group Description	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
Measure Participants	0

2. Secondary Outcome

Title	Number of Reported Adverse Events
Description	Analysis of the reported system or procedure related adverse events using standard AE reporting form
Time Frame	at device implantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NewBreez
Arm/Group Description	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
Measure Participants	2
Number [adverse events]	0

3. Secondary Outcome

Title	Number of Reported Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NewBreez
Arm/Group Description	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
Measure Participants	2
Number [AE reported]	2

4. Secondary Outcome

Title	Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score
Description	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
Time Frame	1 weeks

Outcome Measure Data

Analysis Population Description

Second enrolled patient did not reach the first data point, subj. was explanted prior first measurement.

Arm/Group Title	NewBreez
Arm/Group Description	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
Measure Participants	1
Number [participants]	1 50%

5. Other Pre-specified Outcome

Title	Number of Participants With Reported Device Migration in the Larynx Post Implant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NewBreez
Arm/Group Description	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
Measure Participants	2
Number [participants]	1 50%

6. Other Pre-specified Outcome

Title	Change From Baseline of Quality of Life (QoL) Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Reported Subjective Rating of Comfort of the Device in the Larynx
Description	In patient subjective measure (repeated) of pain score (1-10) and comfort level (questionnaire) at weeks 1,4,8,12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	subject 1: 24 hours after receiving the NewBreez implant subject 2: 11 days after receiving the NewBreez implant
Arm/Group Title	NewBreez
Arm/Group Description	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
All Cause Mortality
	NewBreez
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	NewBreez
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Product Issues
aspiration	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	NewBreez
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Product Issues
Device migration	1/2 (50%)	1

Limitations/Caveats

Very low recruitment achieved over all sites and early termination of the enrolled subjects gives insufficient data for any meaningful analysis of the product performance and safety in this study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.