BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus (B-SILENT)

Sonorous NV, Inc

Status: Not yet enrolling

Conditions: Pulsatile Tinnitus; Venous Sinus Stenosis

Treatments: Device: BosSTENT implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07070089

CIP-001SON

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥18 - 80 years old

2. Able to provide informed consent to participate in the study

3. Severe or catastrophic PST (THI grade ≥ 4; THI score ≥ 58) that responds to jugular vein compression.

4. Cerebral venous sinus stenosis with the following characteristics:

   1. Transverse cerebral venous sinus
   2. >50% stenosis by computed tomography venogram (CTV), magnetic resonance venogram (MRV), or catheter cerebral angiography
   3. Vessel diameter amenable to sizing according to Table 1 below without the need to undersize

5. Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy)

6. Willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up

7. Life expectancy >12 months

Exclusion criteria

1. Dural cerebral venous sinus stenosis secondary to an underlying condition (e.g. brain tumor) that may be treated by alternative established therapies (e.g., surgery, embolization)
2. Previously implanted stent in the target vessel
3. Contraindication to anticoagulant and/or antiplatelet therapy or thrombolytic drugs
4. Target vessel size that does not fall within the indicated range per Table 1 of the IFU
5. History of severe allergy to contrast/contrast media or nickel
6. Non-pulse-synchronous tinnitus
7. Current diagnosis of papilledema
8. Dural arteriovenous fistula or arteriovenous malformation
9. History of untreated atrial fibrillation, untreated/uncontrollable hypertension, or other stroke factors
10. History of deep vein thrombosis or pulmonary embolism
11. History of heart failure, dilated cardiomyopathy, or congenital heart conditions
12. Arterial stenosis, dissection, or aneurysm
13. PST due to causes not related to cerebral venous sinus stenosis
14. Evidence of an active systemic infection
15. Venous sinus thrombosis, jugular compression, venous aberrant or tortuous anatomy that would prevent the safe delivery and deployment of the BosSTENT to the target treatment zone.
16. Cerebral venous sinus diverticulum that, in the Investigator's opinion, requires treatment other than stenting (e.g., coiling)
17. Otologic disorders that may confound PST assessments, including, but not limited to misophonia or hyperacusis
18. Hypercoagulable state or hemorrhagic or coagulation deficiency refractory to medical therapy
19. Suffered a stroke within the past 6 months
20. Platelet count <100x109/L (100,000/µL)
21. Participation in another investigational protocol
22. Immuno-compromised
23. Pregnant or nursing women (females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion)
24. Other clinical conditions, that in the opinion of the Investigator significantly compromise the ability to perform a safe and/or effective procedure
25. Incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

BosSTENT

Experimental group

Treatment:

Device: BosSTENT implantation