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This study is evaluating the safety and clinical performance of the BosSTENT, a new stent designed specifically for treating pulse-synchronous tinnitus due to venous sinus stenosis. The study will evaluate the long-term safety of the BosSTENT as well as its impact on the severity of pulse-synchronous tinnitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BosSTENT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BosSTENT implantation | Device | BosSTENT implantation in the transverse venous sinus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major adverse events (MAE) | MAEs are defined as symptomatic, serious, procedure- or device-related post-procedure complications: major stroke, neurological death, in-stent thrombosis, target vessel restenosis, stent-adjacent stenosis, or stent migration | 3 months |
| Improvement of pulse-synchronous tinnitus measured by a decrease of at least 2 grades or 40 points on the Tinnitus Handicap Inventory (THI) | THI ranges from 0-100 points with zero indicating no handicap due to tinnitus and increasing scores indicating progressively worse handicap due to tinnitus. Grades range from 1-5 going from Slight (0-16 points), to Mild (18-36 points), Moderate (38-56 points), Severe (58-76 points) and finally Catastrophic (78-100 points) | 30 days |
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Inclusion Criteria:
Male or female ≥18 - 80 years old
Able to provide informed consent to participate in the study
Severe or catastrophic PST (THI grade ≥ 4; THI score ≥ 58) that responds to jugular vein compression.
Cerebral venous sinus stenosis with the following characteristics:
Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy)
Willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up
Life expectancy >12 months
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James D Nonato, Pharm D | Contact | +1-949-810-0055 | info@sonorousnv.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Not yet recruiting | Ottawa | Canada | K1Y 4E9 | Canada |
This study is intended to determine incidences of major adverse events and pulse-synchronous tinnitus improvement. While specific events may be summarized in study reports or publications, IPD are not anticipated to be shared.
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Unity Health Toronto - St. Michael's Hospital | Not yet recruiting | Toronto | Canada | M5B 1W8 | Canada |
|
| CHU de Bordeaux | Recruiting | Bordeaux | France | 33000 | France |
|
| CHU Montpelier | Recruiting | Montpellier | France | 34090 | France |
|
| Hôpital de la Pitié Salpêtrière | Not yet recruiting | Paris | France | 75013 | France |
|
| CHRU Tours | Recruiting | Tours | France | 37000 | France |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |