New stent could silence debilitating ringing in the ears
NCT ID NCT07070089
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study tests a new stent called BosSTENT for people with severe pulsatile tinnitus (a rhythmic whooshing sound in the ear) caused by a narrowed vein in the brain. About 90 adults will receive the implant to see if it safely reduces tinnitus severity. The goal is to improve quality of life by easing the constant noise.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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CHRU Tours
RECRUITINGTours, France, 37000, France
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CHU Montpelier
RECRUITINGMontpellier, France, 34090, France
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CHU de Bordeaux
RECRUITINGBordeaux, France, 33000, France
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Hôpital de la Pitié Salpêtrière
NOT_YET_RECRUITINGParis, France, 75013, France
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The Ottawa Hospital
RECRUITINGOttawa, Canada, K1Y 4E9, Canada
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Unity Health Toronto - St. Michael's Hospital
RECRUITINGToronto, Canada, M5B 1W8, Canada
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