Pulsatile TinnitusB-SILENTNCT07070089
BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus
A study testing BosSTENT implantation in people with Pulsatile Tinnitus and Venous Sinus Stenosis, run by Sonorous NV, Inc at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulsatile Tinnitus, Venous Sinus Stenosis
- What is being tested?
- BosSTENT implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Feb 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
France4 sites, 4 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, France, 33000
Dr. Xavier Barreau
Dr. Xavier Barreau
- Recruiting
CHU Montpelier
Montpellier, France, 34090
Prof. Vincent Costalat
Prof. Vincent Costalat
- Not yet recruiting
Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Dr. Stephanie Lenck
Dr. Stephanie Lenck
- Recruiting
CHRU Tours
Tours, France, 37000
Dr. Kevin Janot
Dr. Kevin Janot
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Canada, K1Y 4E9
Dr. Robert Fahed
Dr. Robert Fahed
- Recruiting
Unity Health Toronto - St. Michael's Hospital
Toronto, Canada, M5B 1W8
Prof. Vitor Mendes-Pereira
About this study
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.
- Conditions
- Pulsatile Tinnitus, Venous Sinus Stenosis
- Being tested
- BosSTENT implantation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosSTENT implantationDevice
BosSTENT implantation in the transverse venous sinus
| Study group | Role | What they receive |
|---|---|---|
| BosSTENT | Experimental | Not described Receives: Device: BosSTENT implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Feb 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulsatile TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonorous NV, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070089
- Sponsor's protocol ID
- CIP-001SON
- Acronym
- B-SILENT
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is intended to determine incidences of major adverse events and pulse-synchronous tinnitus improvement. While specific events may be summarized in study reports or publications, IPD are not anticipated to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus
- ClinicalTrials.gov ID
- NCT07070089
- Acronym / sponsor ID
- B-SILENT / CIP-001SON
- Conditions
- Pulsatile Tinnitus, Venous Sinus Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sonorous NV, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BosSTENT | Experimental | Device: BosSTENT implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy)
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosSTENT implantationBosSTENT implantation in the transverse venous sinus | Device | BosSTENT |
Primary outcome
Incidence of Major adverse events (MAE)
Time frame: 3 months
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
Improvement of pulse-synchronous tinnitus measured by a decrease of at least 2 grades or 40 points on the Tinnitus Handicap Inventory (THI)
Time frame: 30 days
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No. This study is intended to determine incidences of major adverse events and pulse-synchronous tinnitus improvement. While specific events may be summarized in study reports or publications, IPD are not anticipated to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BosSTENT implantation in people with Pulsatile Tinnitus and Venous Sinus Stenosis, run by Sonorous NV, Inc at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James D Nonato, Pharm D (+1-949-810-0055, info@sonorousnv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major adverse events (MAE) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.