Intra-laryngeal Implant for Treatment of Chronic Aspirations

Study Overview
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Brief Summary
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This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia.

Detailed Description
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Patients suffering from swallowing disorders characterized by chronic aspirations (repeated episodes of aspirations defined as penetration of material - liquids, food, saliva, into the respiratory system due to a malfunctioning of the swallowing mechanism) are subject to pathologies and pulmonary insufficiencies. The risks of aspiration pneumonia or suffocation are significantly greater if the patient is not able to expectorate and thus engages the vital prognosis. There are several methods to treat chronic aspirations: the least invasive methods involve adopting postures and/or positions of the body during swallowing and adapting food textures; when these treatments are insufficient there is the need to recur to more advanced ones to protect the airways and keep the patient on a sufficient nutrition. For these severe cases, heavier surgical methods can be also considered. These methods lead to important anatomical changes, with a variable degree of reversibility, up to irreversibility (eg total laryngectomy). Among surgical methods, there is also an implant of a tracheotomy cuffed cannula that allows patient to breathe through a hole in the trachea. The efficacy of this solution is highly controversial as reported by numerous studies and several adverse effects are reported on the tracheal duct. Due to the interest of a prosthetic treatment and the disadvantages of the current methods and devices, PROTiP Medical has developed a closed intra-laryngeal implant: NewBreez LD. This device is innovative because its geometry has been optimized to conform totally to the anatomy of the larynx with the aim to ensure a sealing against saliva, liquids and food aspirations.

Official Title
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Intra-laryngeal Implant for Treatment of Chronic Aspirations

Conditions
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Aspiration Pneumonia, Tracheostomy Complication

Intervention / Treatment
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* Device: NewBreez LD intra-laryngeal implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Swallowing disorders characterized by chronic aspirations; Tracheotomy performed, inter alia, in the management of swallowing disorders; Aged over 18; Willing and able to comply with the requirements of the study; Informed consent signed; Affiliated patient or beneficiary of the social security system. Exclusion Criteria: Do not implant in patients with incomplete cricoid cartilage (surgery or other); Do not implant in patients with tracheotomy performed by cricothyroidectomy or between cricoid cartilage and the 1st tracheal ring; Do not implant in patients with tracheal lumen in the 1st tracheal ring, the lateral and anteroposterior diameters of which are less than 11 mm; Do not implant in patients with tight trismus; Do not implant in subjects less than 18 years of age; Do not implant in patients with bleeding disorders; Do not implant in patients contraindicated to general anesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NewBreez LD Intra-laryngeal implant<br> | Device: NewBreez LD intra-laryngeal implant<br>* NewBreez LD intra-laryngeal implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sealing of the NewBreez LD: Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS) | Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS) | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe aspiration