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Due to lack of recruitment and loss of the French principal investigator.
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The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NewBreez ILP | Experimental | Implantation of a NewBreez ILP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NewBreez ILP | Device | NewBreez ILP implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aspiration score at 1 month | Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Remacle, Prof. | UCL Mont-Godinne (Belgium) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Mont-Godinne | Yvoir | 5530 | Belgium | |||
| Hopital Avicenne |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Bobigny |
| 93000 |
| France |
| D010038 | Otorhinolaryngologic Diseases |