Actively Recruiting
BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus
Led by Sonorous NV, Inc · Updated on 2026-04-15
90
Participants Needed
6
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 80 years old
- Able to provide informed consent to join the study
- Severe or catastrophic pulse-synchronous tinnitus with Tinnitus Handicap Inventory grade 4 or higher and score 58 or more, which improves with jugular vein compression
- Cerebral venous sinus stenosis in the transverse sinus with more than 50% narrowing shown by imaging
- Vessel size suitable for BosSTENT implantation without undersizing
- Tried at least one non-invasive therapy for pulse-synchronous tinnitus without sufficient improvement
- Willing to follow study procedures and attend all follow-up visits
- Life expectancy longer than 12 months
You will not qualify if you...
- Cerebral venous sinus stenosis caused by other conditions like brain tumors treatable by different therapies
- Previously placed stent in the target blood vessel
- Contraindications to blood thinners or clot-dissolving drugs
- Target vessel size not fitting the device specifications
- Severe allergy to contrast agents or nickel
- Non-pulse-synchronous tinnitus
- Current papilledema diagnosis
- Dural arteriovenous fistula or malformation
- Untreated atrial fibrillation, uncontrolled hypertension, or other stroke-related conditions
- History of deep vein thrombosis or pulmonary embolism
- History of heart failure or congenital heart conditions
- Arterial stenosis, dissection, or aneurysm
- Pulse-synchronous tinnitus from causes other than cerebral venous sinus stenosis
- Active systemic infection
- Venous sinus thrombosis or vein anatomy preventing safe stent delivery
- Cerebral venous sinus diverticulum requiring other treatments
- Ear disorders interfering with tinnitus assessments
- Blood clotting disorders not controlled by medication
- Stroke within the past 6 months
- Low 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 medical conditions affecting safe or effective treatment
- Unable to understand or provide informed consent due to mental incapacity
AI-Screening
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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
CONTACT
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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