Intra-laryngeal Implant for Treatment of Chronic Aspirations

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03325725
Study type	Interventional
Source	ProTiP Medical
Contact
Status	Withdrawn
Phase	N/A
Start date	January 9, 2018
Completion date	January 9, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.