The importance of clinical trials

The importance of clinical trials

Our Head of Clinical Affairs, Kieron Day has worked in MedTech for 20 years leading clinical studies in MedTech companies. Kieron joined us in 2019 to head up the clinical trials for our leading brand, the geko™ device around the world.

The benefits of broad application

Since joining the Sky team, Kieron has overseen the creation and execution of large-scale, multi-centred clinical trials for the geko™ device.

The geko™ is a platform technology, meaning it can help to address a range of medical conditions. Kieron elaborates, “It is  well-established that if you stimulate a specific nerve in the leg, this will activate the calf and foot muscle pumps, which in turn compresses the vein and increases blood circulation from the leg back to the heart. When this takes place, biologically and physiologically, good things happen. For example, swelling will reduce in patients experiencing oedema, wounds will heal more quickly.”

Patient audit vs. clinical trials

Kieron’s challenge was quickly widening the reach of the geko™ device. When Kieron joined, we already had evidence that geko™ was effective in addressing the risk of deep vein thrombosis (DVT), however this was a real-world patient audit and not a randomised control trial (RCT).

Kieron explains “The geko™ device had been deployed where patients were unable to use the current ‘gold standard’ treatment to reduce the risk of DVT in acute stroke patients – this being Intermittent Pneumatic Compression (IPC). Some 30 percent of patients are unable to tolerate IPC and the geko™ device was successfully providing these patients, at the Royal Stoke Hospital, with a viable alternative. When we took the device to a wider clinical audience, along with the real-world data, many other clinicians embraced its use to address the unmet need. Some, however, see unmet need as a small requirement and wish to see an RCT in order to displace IPC. It’s something we are working on.”

Same product, different therapy and RCT

We are now also completing an RCT around geko™ device impact on venous leg ulcers (VLU). The existing gold standard treatment for VLUs is achieved through compression bandaging of the wound. In this RCT, we are trialling the device on half of the patients to identify whether the combined treatment speeds up wound healing. Kieron comments: “We are extremely close to completing that trial and the interim outcomes are very positive. Current gold standard therapy takes between three months and a year to close a wound, and some never close entirely. We’ve seen the average healing time, in patients using the geko™ device in combination with wound dressing, fall by half.”

Investment is essential

Patience and investment are at the heart of successful clinical trials according to Kieron: “I would love to do all the trials we need to do immediately, across every medical condition, and every country; but ….we need to ensure we can properly manage all of our commitments”. He continues, “MedTech companies should view investment in the clinical trial process as an investment in their own future success, since this will pay significant dividends in terms of commercial success.”

To hear more from Kieron read the full article on Building Better Healthcare.

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