SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
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- STATUS
- Recruiting
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- days left to enroll
- 55
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- participants needed
- 20
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- sponsor
- SonoClear AS
Summary
The objective of this clinical investigation is to assess the safety and performance of the SonoClear Acoustic Coupling Fluid (ACF). The performance will be assessed by analysis of the contrast-to-noise ratio (CNR) and assessment of image quality by using the Surgeon Image Rating (SIR) Scale.
This is a prospective, multi-centre single-arm study where the performance of SonoClear ACF relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of HGG and LGG at up to 4 sites will be included. Additionally, safety data are collected up to 30 days post-procedure.
Description
The SonoClear ACF will be used in combination with conventional ultrasound imaging equipment, with the transducer positioned at the cortex or on top of the surgical entry point in the brain. Any CE-marked ultrasound system and transducer that can provide high-level image quality may be used.
The study is a pivotal single-arm trial in 3 or 4 centres on approximately 20 participants with either low grade (WHO Grade I/II) or high grade (WHO Grade III/IV) gliomas undergoing primary surgery, to collect performance and safety data on Sonoclear ACF in comparison with saline solution (the saline standard of care) as an acoustic coupling fluid during ultrasound imaging in brain surgery.
There are two primary performance outcomes, Contrast-to-Noise Ratio (CNR) to quantify the reduction in noise and the Surgeons Image Rating (SIR) to assess the image quality and a primary safety outcome. The two primary performance outcomes will be addressed in a hierarchical gatekeeping approach. First, the SonoClear ACF will be tested for superiority over saline with respect to reduced image artefacts as detected by CNR. Besides the superiority of SonoClear ACF on CNR, it will be tested for superiority over saline using SIR. SIR is designed to assess if the expert panel, given an objective improvement in the quantitative CNR measures, can see a difference in image quality which potentially may help surgeons to deliver better excisional margins and more complete tumour resection (which might then lead to improved patient outcomes). By specifying this gatekeeping hierarchy, we present the two performance outcomes which are important clinically and in their logical order, and in such a way that the statistical chance of a false positive (a type 1 error) is still controlled at the usual 5% without the need for adjustment for multiple comparisons.
The primary analysis will be according to a modified Intention to Treat (mITT) set, which is a subset of the safety set and will include all participants who have a biopsy confirmed glioma and who have a complete set of interpretable images for each of the performance outcomes (i.e. an interpretable image on both SonoClear ACF and saline for both the CNR and the SIR outcomes showing the tumour).
The safety set will be defined as all participants who received at least one dose of SonoClear ACF.
Details
| Condition | Brain Tumour, High Grade Glioma, Low-grade Glioma, Glioblastoma |
|---|---|
| Treatment | SonoClear ACF |
| Clinical Study Identifier | NCT04734444 |
| Sponsor | SonoClear AS |
| Last Modified on | 6 April 2022 |
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