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New treatment option for Pulsatile Tinnitus
Official title BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus
ClinicalTrials.gov ID: NCT07070089
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
- Cerebral venous sinus stenosis with the following characteristics:
- Transverse cerebral venous sinus
You likely can't join if
- Dural cerebral venous sinus stenosis secondary to an underlying condition (e.g. brain tumor) that may be treated by alternative established therapies...
- 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
- History of severe allergy to contrast/contrast media or nickel
- Non-pulse-synchronous tinnitus
See the full eligibility criteria
- 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.
- Cerebral venous sinus stenosis with the following characteristics:
- Transverse cerebral venous sinus
- \>50% stenosis by computed tomography venogram (CTV), magnetic resonance venogram (MRV), or catheter cerebral angiography
- Vessel diameter amenable to sizing according to Table 1 below without the need to undersize
- Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy)
- Willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up
- Life expectancy \>12 months
- 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
- History of severe allergy to contrast/contrast media or nickel
- Non-pulse-synchronous tinnitus
- Current diagnosis of papilledema
- Dural arteriovenous fistula or arteriovenous malformation
- History of untreated atrial fibrillation, untreated/uncontrollable hypertension, or other stroke factors
- History of deep vein thrombosis or pulmonary embolism
- History of heart failure, dilated cardiomyopathy, or congenital heart conditions
- Arterial stenosis, dissection, or aneurysm
- PST due to causes not related to cerebral venous sinus stenosis
- Evidence of an active systemic infection
- 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.
- Cerebral venous sinus diverticulum that, in the Investigator's opinion, requires treatment other than stenting (e.g., coiling)
- Otologic disorders that may confound PST assessments, including, but not limited to misophonia or hyperacusis
- Hypercoagulable state or hemorrhagic or coagulation deficiency refractory to medical therapy
- Suffered a stroke within the past 6 months
- Platelet count \<100x109/L (100,000/µL)
- Participation in another investigational protocol
- Immuno-compromised
- 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)
- Other clinical conditions, that in the opinion of the Investigator significantly compromise the ability to perform a safe and/or effective procedure
- Incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Canada, Canada
- Toronto, Canada, Canada
- Bordeaux, France, France
- Montpellier, France, France
- Paris, France, France
- Tours, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Canada, Canada; Toronto, Canada, Canada; Bordeaux, France, France; Montpellier, France, France; Paris, France, France; Tours, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.