Excellent results of Cranial LOOP in clinical study

An ongoing randomized clinical trial comparing Cranial LOOP and a titanium counterpart indicates high user satisfaction (8/10) with NEOS Surgery’s product.

An ongoing randomized clinical trial comparing Cranial LOOP and a titanium counterpart indicates high user satisfaction (8/10) with NEOS Surgery’s product. In this study, satisfaction with the devices during its implantation in the OR is evaluated based on the neurosurgeons’ agreement with three statements: 1) the device is easy to use, 2) the device shows good adaptation to the skull, and 3) the device offers reliable fixation. By adding up the marks that surgeons give to these three concepts, a global satisfaction value is obtained for each implantation.

This clinical trial is being carried out at the Hospital de la Santa Creu i Sant Pau, a University Hospital located in Barcelona. The study plans to enroll a total of 80 patients and allocate them randomly to two different groups: one treated with Cranial LOOP and one treated with a titanium-based clamping system. The results so far (with approximately half of the implantations carried out) show that neurosurgeons are highly satisfied with Cranial LOOP. Apart from satisfaction with implantation, the appearance of complications during the first year after the surgical procedure will also be monitored. Until now, no incidents have been reported in patients treated with Cranial LOOP. Finally, a further aspect being evaluated is the presence and effect of artifacts: clinicians confirm that Cranial LOOP does not cause any artifact in medical imaging (either CT scanning or MRI), and thus facilitates patient follow-up.

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