Actively Recruiting
BosSTENT Implant to Treat Debilitating Pulse-Synchronous Tinnitus
Led by Sonorous NV, Inc · Updated on 2026-04-15
90
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical performance of the BosSTENT, a new medical device designed specifically to treat pulse-synchronous tinnitus caused by venous sinus stenosis. The study aims to assess the long-term safety of the BosSTENT and its effect on reducing the severity of this type of tinnitus. This interventional trial is sponsored by Sonorous NV, Inc and targets adult participants aged 18 to 80 years with severe pulse-synchronous tinnitus that responds to jugular vein compression. Participants will undergo BosSTENT implantation in the transverse venous sinus. The study involves monitoring the incidence of major adverse events within three months after implantation and measuring improvement in tinnitus severity at 30 days using the Tinnitus Handicap Inventory (THI). The trial does not include a comparator group or masking. The device is implanted to evaluate its therapeutic potential in this specific condition. During the study, participants must comply with all protocol requirements and attend clinical evaluations and follow-up visits. Researchers will track safety and tinnitus outcomes through clinical assessments and the THI questionnaire. The total study participation will extend at least three months after the procedure to monitor adverse events and treatment impact. Participants' long-term health and tinnitus changes will be carefully observed under medical supervision throughout the trial period.
CONDITIONS
Brief Title
BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years
- Able to provide informed consent to participate in the study
- Severe or catastrophic pulse-synchronous tinnitus (THI grade 2 4; THI score 2 58) that responds to jugular vein compression
- Cerebral venous sinus stenosis in the transverse sinus with more than 50% narrowing confirmed by CT venogram, MR venogram, or cerebral angiography
- Vessel size suitable for BosSTENT implantation per device guidelines
- Tried at least one non-invasive therapy for pulse-synchronous tinnitus without success
- Willing to comply with study protocol and attend all clinical evaluations and follow-ups
- Life expectancy greater than 12 months
You will not qualify if you...
- Venous sinus stenosis caused by other conditions like brain tumor treatable by other therapies
- Previously implanted stent in the target vessel
- Contraindications to anticoagulant, antiplatelet, or thrombolytic medications
- Vessel size outside the device's approved range
- Severe allergy to contrast agents or nickel
- Non-pulse-synchronous tinnitus
- Current diagnosis of papilledema
- Presence of dural arteriovenous fistula or malformation
- Untreated atrial fibrillation, uncontrolled hypertension, or other stroke risk factors
- History of deep vein thrombosis or pulmonary embolism
- History of heart failure, cardiomyopathy, or congenital heart disease
- Arterial stenosis, dissection, or aneurysm
- Pulse-synchronous tinnitus not related to venous sinus stenosis
- Active systemic infection
- Venous sinus thrombosis or anatomy preventing safe device delivery
- Cerebral venous sinus diverticulum needing other treatment
- Otologic disorders affecting tinnitus assessments
- Blood clotting disorders not controlled by medication
- Stroke within the past 6 months
- Platelet count below 100,000 per microliter
- Participation in another investigational study
- Immunocompromised status
- Pregnant or nursing women; females under 45 must have a negative pregnancy test
- Other conditions that could affect safety or effectiveness
- Unable to understand or provide informed consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo BosSTENT implantation in the transverse venous sinus to treat pulse-synchronous tinnitus.
1 visit (in-person)
Duration - Up to 3 months
Participants are monitored for safety and improvement of pulse-synchronous tinnitus after BosSTENT implantation.
Approximately 3 visits for assessments over 3 months
Trial Site Locations
Total: 6 locations
1
The Ottawa Hospital
Ottawa, Canada, Canada, K1Y 4E9
Not Yet Recruiting
2
Unity Health Toronto - St. Michael's Hospital
Toronto, Canada, Canada, M5B 1W8
Not Yet Recruiting
3
CHU de Bordeaux
Bordeaux, France, France, 33000
Actively Recruiting
4
CHU Montpelier
Montpellier, France, France, 34090
Actively Recruiting
5
Hôpital de la Pitié Salpêtrière
Paris, France, France, 75013
Not Yet Recruiting
6
CHRU Tours
Tours, France, France, 37000
Actively Recruiting
Research Team
J
James D Nonato, Pharm D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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