NeuraSignal has published clinical trial data for its flagship NovaGuide Intelligent Ultrasound system showing the device’s efficacy in detecting right to left shunts (RLS).

The data from the single-arm BUBL clinical trial (NCT04604015) was published in the American Heart Association journal, Stroke.

The NovaGuide system is a robot-assisted transcranial Doppler (TCD), a non-invasive diagnostic test to detect RLS, including patent foramen ovale, which is a recognised risk factor for strokes.

The clinical trial compared the efficacy of NovaGuide in detecting RLS compared with the current diagnostic standard, transthoracic echocardiography (TTE).

“An accurate assessment for RLS is a critical part of evaluating patients with cryptogenic ischaemic stroke. While TTE has long been the most common screening diagnostic for RLS, we know from decades of TCD experience that TTE falls short as a screening tool,” said the principal trial investigator, Mark N Rubin.

“TCD expertise is rare, which means most doctors and patients have no idea what TCD is and what it can do for them. The democratisation of technique with robotic and software tools has made TCD, finally, as ‘push button’ as I have seen it in my career so far, which I sincerely hope translates into these advanced diagnostic tools helping patients.”

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The use of robotics in healthcare has been increasing in recent years. GlobalData forecasts that the robotics industry will grow from $63bn in 2022 to $218bn in 2030.

GlobalData is the parent company of Clinical Trials Arena.

Clinical trial data

The trial enrolled 129 patients across six sites in the US. The study met its primary endpoint, with NovaGuide detecting RLS in 64% of the cases compared with the TTE, which detected RLS in 20% of the patients. No serious adverse events were observed with NovaGuide in the trial.

The study also compared manual TCD to the robot-guided NovaGuide. The results showed that the robot was more sensitive to RLS detection, with NovaGuide and manual TCD detecting RLS in 85.7% and 57.1% of the participants, respectively.