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The primary study goal is to evaluate the histological characteristic of Silk Voice to evaluate the potential for Silk Voice to deliver long-term results to patients.
The primary study goal is to evaluate the histological characteristic of Silk Voice at a surrogate implantation site to evaluate the potential for Silk Voice to deliver long-term results to patients. Information obtained from this study will help clinician determine Silk Voice's treatment duration and whether Silk Voice is appropriate for their patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 month explant | Other | Silk Voice and control material are implanted. The implanted material is explanted at 6 months. |
|
| 12 month explant | Other | Silk Voice and control material are implanted. The implanted material is explanted at 12 months. |
|
| 24 month explant | Other | Silk Voice and control material are implanted. The implanted material is explanted at 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silk Voice | Device | Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation. | Tissue samples extracted at 6 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed. | 6 month |
| Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation. | Tissue samples extracted at 12 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed. | 12 month |
| Number of subjects exhibiting histological evidence of newly deposited tissue compared to control implantation. | Tissue samples extracted at 24 -month time points will be qualitatively evaluated for presence of tissue deposition. Changes in tissue composition will be assessed. | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient and number of reported adverse events reported | Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated. | 6 month |
| Number of patient and number of reported adverse events reported |
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Inclusion Criteria:
To be eligible for enrollment, the Subject must meet the following:
Exclusion Criteria:
Patients will not enroll in the study if they meet any of the following exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Chicago | Illinois | 60611 | United States |
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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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Each subject enrolled will receive implantation of both Silk Voice and control material.
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Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated. |
| 12 month |
| Number of patient and number of reported adverse events reported | Localized adverse event associated with material implantation. The number of patients and type of adverse events will be evaluated. | 24 month |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |