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

NCT02437513 | Terminated Results

• 1 other identifier: NB for HNC
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aspiration; Laryngeal Cancer

Keywords

Dysphagia; Aspiration; Laryngeal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Reported Adverse Events

  at device implantation

• Number of Reported Adverse Events

  2 weeks

• Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score

  1 weeks

Other Outcomes (3)

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

  1 weeks

• Change From Baseline of Quality of Life (QoL) Score

  12 weeks

• Reported Subjective Rating of Comfort of the Device in the Larynx

  12 weeks

Study Arms (1)

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

Interventions

NewBreez DEVICE

Intralaryngeal prosthesis to protect the airways

Also known as: Intralaryngeal Prosthesis

NewBreez

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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®
• years of age or older
• Sufficient cognitive function to comply with the study and follow-up requirements
• Patient gives voluntary signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• ProTiP Medical: lead

MeSH Terms

Conditions

Laryngeal Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Limitations and 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.

Results Point of Contact

• Title: Linda Nicolini CEO
• Organization: Protip Medical

l.nicolini@protipmedical.com

0033388103068

Study Officials

• Ursula Schroeder, Dr. med.

  University of Luebeck

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 7, 2015
• Study Start: March 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 24, 2017
• Results First Posted: August 24, 2017

Record last verified: 2017-04