Stent could silence ringing in the ear
NCT ID NCT06726928
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a stent called SiREX to treat pulsatile tinnitus—a rhythmic ringing in the ear—caused by a narrowed vein in the brain. About 78 adults with symptoms lasting over three months will receive the stent. The main goal is to see if the tinnitus disappears 90 days after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SiREX stent
- What this could lead to
- If it works, this could provide a lasting solution for people with disabling pulsatile tinnitus caused by a narrowed sinus vein.
- What could go wrong
- This is a small, early-stage trial with only 78 participants. The stent procedure carries risks like bleeding or infection, and the tinnitus may not fully resolve.
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
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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 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
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 years and older
- 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.
Show the full entry requirements Hide 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: * • Patient ≥ 18 years old * Disabling pulsatile tinnitus lasting for more than three months * Venous type: pulsatile tinnitus is interrupted by ipsilateral jugular vein compression * Lateral sinus stenosis visible on venous MRA or venous angio CT * Exclusion of other cause (excepted dehiscence of the lateral sinus related to the stenosis) of PT on MRI and on the temporal bone CT * Stenosis located on a dominant or codominant lateral sinus * Stenosis associated with a venous gradient of at least 3 mm Hg under general anesthesia (GA) in the absence of sinus dehiscence, or 2 mm Hg under GA if there is sinus dehiscence in a mastoid cell * Patients asking for the treatment of her/his pulsatile tinnitus * Patients accepting to receive the SiREX® Stent (instead of a carotid stent) * Written informed consent Exclusion Criteria: * Non-pulsatile tinnitus or pulsatile tinnitus unrelated to lateral sinus stenosis * Stenosis with gradient \< 2 mm Hg in the absence of associated lateral sinus dehiscence * Any contraindication for treatment according to Instructions for Use: * Patients in whom the size of the venous vessel section to be treated does not lie within the range indicated for the stent. * Patients for whom angiography shows that the anatomic morphology is not suitable for endovascular treatment due to severe vessel tortuosity or stenosis.Patients who were not pre-treated with antiplatelet agents prior to the procedure. * Patients in whom treatment with antiplatelet agents and/or anticoagulants is contraindicated. * Patients with an acute subarachnoid haemorrhage. * Patients with an active bacterial infection. * Patients who are hypersensitive to nickel-titanium. * Pregnant or breastfeeding woman * Subject is participating in another clinical study * Patients with a life-threatening event in the last 6 months * Patients with a life expectancy under 12 months * Known, severe comorbidities, which will likely influence carrying out of the follow-up visits (cancer, alcohol/drug abuse or dementia)
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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
1 site. 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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Hôpital Lariboisière
RECRUITINGParis, 75010, France