Intra-laryngeal Implant for Treatment of Chronic Aspirations
Primary Purpose
Aspiration Pneumonia, Tracheostomy Complication
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NewBreez LD intra-laryngeal implant
Sponsored by
About this trial
This is an interventional device feasibility trial for Aspiration Pneumonia focused on measuring severe aspiration
Eligibility Criteria
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.
Sites / Locations
- CHU Strasbourg
- CHU Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NewBreez LD Intra-laryngeal implant
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03325725
Brief Title
Intra-laryngeal Implant for Treatment of Chronic Aspirations
Official Title
Intra-laryngeal Implant for Treatment of Chronic Aspirations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The Competent Authority did not give the authorization to start the study.
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
January 9, 2018 (Actual)
Study Completion Date
January 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProTiP Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia, Tracheostomy Complication
Keywords
severe aspiration
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NewBreez LD Intra-laryngeal implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NewBreez LD intra-laryngeal implant
Intervention Description
NewBreez LD intra-laryngeal implantation
Primary Outcome Measure Information:
Title
Sealing of the NewBreez LD: Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)
Description
Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Stability of the NewBreez LD: Number of patients who kept the implant until the end of the study period.
Description
Number of patients who kept the implant until the end of the study period.
Time Frame
30 days
Title
Safety of the NewBreez LD: Number of patient with adverse events will be assessed at each follow-up during the study period
Description
Number of patient with adverse events will be assessed at each follow-up during the study period
Time Frame
2, 7, 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Debry, Pr.
Organizational Affiliation
CHU Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Intra-laryngeal Implant for Treatment of Chronic Aspirations
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