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

Aspiration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02437513
• Other study ID #: NB for HNC
• Status: Terminated
• Phase: N/A
• First received: April 23, 2015
• Last updated: August 23, 2017
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: ProTiP Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspiration
• Head and Neck Neoplasms
• Laryngeal Cancer
• Laryngeal Neoplasms

Intervention

Device:
• NewBreez
Intralaryngeal prosthesis to protect the airways

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ProTiP Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	1 weeks
Other	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	12 weeks
Other	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	12 weeks
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	12 weeks
Secondary	Number of Reported Adverse Events	Analysis of the reported system or procedure related adverse events using standard AE reporting form	at device implantation
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	2 weeks
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; = Mild, some difficulty; = Moderate Difficulty but can continue; = Severe difficulty, cannot continue	1 weeks