Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2012-05-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NewBreez ILP
Implantation of a NewBreez ILP
NewBreez ILP
NewBreez ILP implantation
Interventions
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NewBreez ILP
NewBreez ILP implantation
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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ProTiP Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Remacle, Prof.
Role: PRINCIPAL_INVESTIGATOR
UCL Mont-Godinne (Belgium)
Locations
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CHU Mont-Godinne
Yvoir, , Belgium
Hopital Avicenne
Bobigny, , France
Countries
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Other Identifiers
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PIL-02-PEC-1-A
Identifier Type: -
Identifier Source: org_study_id
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