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Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial.
This is a low risk medical device trial [ 35].
The cohort of studies includes a medical device trial (BASICS), another drug trial (TAILOR), a microbiology study (DINOSAUR Micro).
This was an investigator-led, single-center, randomized, open-label, three-setting, crossover device trial, with replicate testing in each setting.
In the CASCADE (CAncelous Structured Ceramic Arthrodesis DEvice) trial, we will randomly and blindly compare anterior discectomy with ceramic cages versus anterior discectomy with PEEK cages.
Similar to previous medication-based studies [ 1, 4, 8, 14- 16], our self-reported adherence rate in this device trial was slightly higher than the electronic monitoring approach; however, the difference was minimal.
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Such training is fairly common in device trials.
Dr. Stratton had also led a group that oversaw all drug and device trials for the University of Arizona Medical Center.
Those made to the test device during the Experimental (Device) trials were generally the longest glances compared to all other locations in both the Baseline and Experimental (No Device) - Fig. 3.
The aim of this article is to provide recommendations to regulatory agencies and research sponsors regarding the use of health status measures in medical device trials.
Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations.
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