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New stent could silence debilitating ringing in the ears

NCT ID NCT07070089

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

Tinnitus

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CHRU Tours

    RECRUITING

    Tours, France, 37000, France

  • CHU Montpelier

    RECRUITING

    Montpellier, France, 34090, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, France, 33000, France

  • Hôpital de la Pitié Salpêtrière

    NOT_YET_RECRUITING

    Paris, France, 75013, France

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Canada, K1Y 4E9, Canada

  • Unity Health Toronto - St. Michael's Hospital

    RECRUITING

    Toronto, Canada, M5B 1W8, Canada

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