BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus

NCT07070089 | Recruiting DMC

• 1 other identifier: CIP-001SON
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Pulsatile Tinnitus; Venous Sinus Stenosis

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  30 days

Study Arms (1)

BosSTENT

EXPERIMENTAL

Device: BosSTENT implantation

Interventions

BosSTENT implantation DEVICE

BosSTENT implantation in the transverse venous sinus

BosSTENT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• \>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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonorous NV, Inc: lead

Study Sites (6)

The Ottawa Hospital

Ottawa, Canada, K1Y 4E9, Canada

NOT YET RECRUITING

Unity Health Toronto - St. Michael's Hospital

Toronto, Canada, M5B 1W8, Canada

NOT YET RECRUITING

CHU de Bordeaux

Bordeaux, France, 33000, France

RECRUITING

CHU Montpelier

Montpellier, France, 34090, France

RECRUITING

Hôpital de la Pitié Salpêtrière

Paris, France, 75013, France

NOT YET RECRUITING

CHRU Tours

Tours, France, 37000, France

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

James D Nonato, Pharm D

CONTACT

+1-949-810-0055; info@sonorousnv.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 17, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); FR (4)