The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez
intra-laryngeal implant in patients with dysfunctional larynx.
Device: NewBreez ILP
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Locations near you
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Full eligibility criteria for NCT01587664
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Age > 18 years old
Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation
Must be able to understand and be willing to provide written informed consent
Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device
Major swallowing disorder
Existing coagulation disorder
Previous esophageal stenting
Life-expectancy < 12 months
Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment
All locations for NCT01587664
Yvoir, Belgium, 5530
Bobigny, France, 93000
View full eligibility
Tris trial is registered with FDA with number: NCT01587664. The sponsor of the trial is ProTiP Medical and it is looking for 2 volunteers for the current phase.
Official trial title: Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis
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