BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus

ConditionsPulsatile Tinnitus Venous Sinus Stenosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorSonorous NV, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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.

Transverse cerebral venous sinus

Disqualifiers

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)

Previously implanted stent in the target vessel

Contraindication to anticoagulant and/or antiplatelet therapy or thrombolytic drugs

Target vessel size that does not fall within the indicated range per Table 1 of the IFU