Earlier in 2020 Ultra Select Medical was tasked with the evaluation of a new 3D ultrasound probe. We worked with it in the lab to look at livers first. Then we needed to run it in the real life setting of a clinic to see how it performs under heavy workflow. Shifa Clinic of Mount Pleasant allowed us to work in their office for which we were very grateful. The study included eight patients who were between the gestational ages of 22 to 28 weeks. This was a small cohort because of the inclusions and exclusions.
We designed the protocol which was approved by the sponsor. Since protocols are confidential that will not be discussed here. The 2D images were carefully evaluated because no two people image the same way. Once the 2D images were known to be of good quality then we proceeded to the 3D. Babies did not abide by protocols and hold still for examinations to be completed so our protocol had to have enough flexibility to account for this. The good thing with trials and ultrasound is that each exam is given plenty of time to complete rather than being pigeon holed into just being allotted a half hour in normal patient care settings. This time was always well used. Then all images came back to the lab for review.
Usually we knew right away if the images were acceptable. What happens if things do not work out the way you planned? This was the reason that some projects were ended. Devices went back to the drawing board for a reboot. In this case multiple factors were adjusted to improve the acquisition and the image quality. However most of the adjustments did not work. Each patient had plenty of fluid and one had an anterior to left lateral placenta. This meant only one thing: the algorithm was off. This is a real problem for the engineers in development because they are the ones who need to figure out if it is the machine, the probe or the way the probe is dialed into the machine that was the issue. Since the probes and the machines are already built there is considerable expense involved in the improvements needed to make the best images possible.
We were very lucky that we had this opportunity to provide the manufacturer with this unbiased data. Our trial patients are the best. Our many thanks go out to Shifa Clinic. The passion that all of us have for the improvement of the ultrasound world continues to be evident in all that we do.
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