BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus
NCT07070089 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-04-15
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
Interventions
- DEVICE
-
BosSTENT implantation
BosSTENT implantation in the transverse venous sinus
Sponsors & Collaborators
-
Sonorous NV, Inc
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2027-07-31
- Completion
- 2028-07-31
Countries
- Canada
- France
Study Locations
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