Status:
WITHDRAWN
Intra-laryngeal Implant for Treatment of Chronic Aspirations
Lead Sponsor:
ProTiP Medical
Conditions:
Aspiration Pneumonia
Tracheostomy Complication
Eligibility:
All Genders
18+ years
Phase:
NA
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 tha...
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 sys...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03325725
Start Date
January 9 2018
End Date
January 9 2018
Last Update
January 12 2018
Active Locations (2)
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1
CHU Strasbourg
Strasbourg, France, 67000
2
CHU Toulouse
Toulouse, France, 31000