Swallowing Disorders
Conditions
Keywords
Swallowing disorders, Aspiration
Brief summary
The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.
Interventions
DEVICENewBreez ILP
NewBreez ILP implantation
Sponsors
ProTiP Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years old 2. Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations 3. Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit 4. 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 5. Must be able to understand and be willing to provide written informed consent
Exclusion criteria
1. Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device 2. Major swallowing disorder 3. Existing coagulation disorder 4. Previous esophageal stenting 5. Life-expectancy \< 12 months 6. Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aspiration score at 1 month | 1 month | Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study |
Countries
Belgium, France
Outcome results
None listed