Sonorous Neurovascular has announced the first patient enrolment in Canada within its international B-SILENT study. The enrolment took place at the Ottawa Hospital (Ottawa, Canada) under principal investigator Robert Fahed, marking “an exciting step forward” for the study’s global expansion, as stated by the company.
“As principal investigator for the B-SILENT study at the Ottawa Hospital, I’m encouraged by the successful enrolment of our first patient,” Fahed commented. “Pulsatile tinnitus can be a debilitating and often under-recognised condition, and studies like B-SILENT are important steps toward giving physicians new tools to help patients who have limited options today. I look forward to our site’s continued contribution to this study.”
The B-SILENT study is evaluating the investigational use of the BosSTENT device—Sonorous’s braided, self-expanding cerebral venous stent for the treatment of debilitating pulsatile tinnitus caused by symptomatic cerebral venous sinus stenosis. The study is designed to generate essential safety and performance data to support a future CE-mark submission.
This Ottawa Hospital enrolment marks the first in Canada under B-SILENT and reflects the study’s growing global momentum, Sonorous claims, also relaying in a press release that site engagement across France remains strong with patient enrolment continuing to progress steadily.
“Achieving our first enrolment in Ottawa is an important milestone for Sonorous Neurovascular and, most importantly, for patients living with debilitating pulsatile tinnitus,” said Joel Harris, chief executive officer (CEO) of Sonorous. “With four sites already actively enrolling in France and now our first Canadian enrolment complete, B-SILENT is advancing exactly as planned. We are grateful to Dr Fahed and the team at the Ottawa Hospital for their partnership, and to our study teams across France and Canada for the continued momentum. This is an exciting step forward for the programme and for the patients we aim to serve.”
