Intra-laryngeal Implant for Treatment of Chronic Aspirations

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.

Study Overview

• Status: Withdrawn
• Conditions: Aspiration Pneumonia; Tracheostomy Complication
• Intervention / Treatment: Device: NewBreez LD intra-laryngeal implant

Detailed 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • CHU Strasbourg
  • Toulouse, France, 31000
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NewBreez LD Intra-laryngeal implant	Device: NewBreez LD intra-laryngeal implant; NewBreez LD intra-laryngeal implantation

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability of the NewBreez LD: Number of patients who kept the implant until the end of the study period.	Number of patients who kept the implant until the end of the study period.	30 days
Safety of the NewBreez LD: Number of patient with adverse events will be assessed at each follow-up during the study period	Number of patient with adverse events will be assessed at each follow-up during the study period	2, 7, 30 days

Collaborators and Investigators

• Sponsor: ProTiP Medical
• Investigators: Principal Investigator: Christian Debry, Pr., CHU Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): January 9, 2018
• Study Completion (Actual): January 9, 2018

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: severe aspiration
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Pneumonia, Aspiration
• Other Study ID Numbers: NB_LD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No