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The first non-invasive device to detect kidney reflux in children

Periodic Reporting for period 1 - Kite (The first non-invasive device to detect kidney reflux in children)

Reporting period: 2020-09-01 to 2021-08-31

Kite Medical is developing the first safe, non-invasive and easy-to-use VUR detection method without radiation or trauma. Vesicoureteral reflux (VUR) is the most common urinary tract abnormality in babies and children up to five years. VUR is the single leading cause of kidney damage, accounting for 25% of all children without kidney function that require a transplant or dialysis.
Early diagnosis is vital, but current diagnostic techniques are invasive and either involve radiation exposure or are unreliable. The gold standard voiding cystourethrogram (VCUG) is traumatising and painful for the child and is stressful for parents and clinicians. The VCUG requires children to undergo urethral catheterisation, radiation exposure and forced bladder filling and emptying while awake. Behaviours of children after a VCUG are consistent with symptoms related to post-traumatic stress disorder.
The overall objectives of the EU-funded project are to advance the technology to limit the impact of motion in the signal (first reporting period) and to subsequently evaluate the clinical performance of a prototype system.
A review of the state of the art in bioimpedance was conducted in light of the signal noise observed during a clinical evaluation in 2018/19. The review determined that hardware improvements and a 3D electrode arrangement to allow 3D electrical impedance tomography (3D EIT) could improve the signal to noise ratio (SNR). EIT uses impedance values to create a tomographic image, where electrode arrays around the regions of interest generate 3D images and provide a more accurate representation of changes in the kidneys and bladder. The company decided to bring EIT expertise in-house and hired Dr. Alistair Boyle (EIT expert) as CTO.
The system includes hardware, firmware and software elements under development in accordance with medical device standards and includes features to improve the SNR. The advance to 3D EIT has resulted in a significantly improved system that incorporates more electrodes and complementary sensors to detect shape and movement.
To effectively assess the suitability of the 3D EIT system, a preclinical study was warranted. A VUR model was created in pigs by stenting the bladder-ureter junction and fluoroscopy confirmed the presence of VUR. Multiple runs were performed with and without movement, the data generated is currently under analysis.
3D EIT is the current state of the art in bioimpedance for lung function and bladder monitoring. It has not been used to monitor changes in the kidneys. With the addition of complementary sensors to measure motion and sophisticated algorithms to filter and analyse the impedance data, the team is developing a system to address the technical challenge of detecting VUR and minimising the impact from external noise in the signal. The next step is to develop a suitable patient interface to enable the system to proceed to clinical evaluation.
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