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The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVFP correction surgery | Experimental | Short-term implantation of VOIS and evaluation of voice quality and glottal closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thyroplasty implant | Device | Short-term implantation of thyroplasty implant, VOIS, and evaluation of voice quality and glottal closure. After evaluation, remove VOIS and perform medialization of vocal folds using conventional thyroplasty. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in voice quality by RBH-Scale | Roughness(R), Breathiness(B), Hoarseness(H) Scale will be rated on a 4-point severity scale (0, normal; 1, mild deviance; 2, moderate deviance; and 3, severe deviance). | pre-surgery, right after temporarily implantation |
| Change in Glottal closure by Södersten and Lindestad classification | pre-surgery, right after temporarily implantation | |
| Change in maximum phonation time in seconds | The prolongation of a/a:/, for as long as possible after maximal inspiration, and at a spontaneous, comfortable pitch and loudness. | pre-surgery, right after temporarily implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of surgical handling and device fitting using a VAS scale | Visual analogue scale(VAS) of Subjective Surgeon Satisfaction will be rated from 0 to 10. (0= not satisfied, 10= very satisfied) | right after temporarily implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berit Schneider-Stickler, Dr. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria |
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| ID | Term |
|---|---|
| D014826 | Vocal Cord Paralysis |
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020421 | Vagus Nerve Diseases |
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| ID | Term |
|---|---|
| D058753 | Laryngoplasty |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |