WithdrawnNot Applicable

Intra-laryngeal Implant for Treatment of Chronic Aspirations

Stopped: The Competent Authority did not give the authorization to start the study.

France0Started 2018-01-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Sealing of the NewBreez LD: Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)

Timeframe: 7 days

Trial details

NCT IDNCT03325725

SponsorProTiP Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-09

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