BosSTENT ImpLant to trEat debilitatiNg 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

This trial does not accept healthy volunteers

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

Trial design

Design model

Single group

Treatments tested in this trial

BosSTENT implantation
Device
BosSTENT implantation in the transverse venous sinus

Treatment groups

90 Participants

are divided into 1 treatment group

Group A: BosSTENTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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)

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sonorous NV, Inc

Lead sponsor

Source ClinicalTrials.gov

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