Introduction to Device Trials
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10.1177/1538574419836316
In device trials, antithrombotic regimens in patients receiving peripheral vascular interventions have not been clearly reported on.
In device trials, antithrombotic regimens in patients receiving peripheral vascular interventions have not been clearly reported on.
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10.1016/j.jcin.2019.01.229
Standardization of the most critical clinical and angiographic endpoints enables interpretability and comparability of different device trials.
Standardization of the most critical clinical and angiographic endpoints enables interpretability and comparability of different device trials.
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10.1136/neurintsurg-2018-014684
Conclusion In light of documented adverse neurologic effects, the frequency of intrathrombus polymer particulates indicates the need for consensus testing methods and large-scale long-term prospective clinical device trials, with inclusion of relevant endpoints to better assess biomaterial and device risks to patients.
Conclusion In light of documented adverse neurologic effects, the frequency of intrathrombus polymer particulates indicates the need for consensus testing methods and large-scale long-term prospective clinical device trials, with inclusion of relevant endpoints to better assess biomaterial and device risks to patients.
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10.1016/J.CARDFAIL.2019.07.219
Methods We evaluated current ACC/AHA/HFSA and ESC HF guidelines and the GDMT definition in 8 HF drug and device trials.
Methods We evaluated current ACC/AHA/HFSA and ESC HF guidelines and the GDMT definition in 8 HF drug and device trials.
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10.1016/J.YGYNO.2019.09.007
Interventional, drug and device trials were not significantly more likely to be completed.
Interventional, drug and device trials were not significantly more likely to be completed.
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10.1007/s41669-019-0137-0
ResultsOur sample consisted of 18 device trials initiated between January 2012 and January 2016.
ResultsOur sample consisted of 18 device trials initiated between January 2012 and January 2016.
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10.1111/cxo.12889
As the field of retinal prostheses advances, volunteers are required for device trials, and optimal participant recruitment is vital for intervention success.
As the field of retinal prostheses advances, volunteers are required for device trials, and optimal participant recruitment is vital for intervention success.
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10.1161/STROKEAHA.119.026717
Conclusions- Noninferiority margins used in EVT device trials have regularly exceeded the MCIDs determined by stroke experts, as well as margins used for cardiac devices.
Conclusions- Noninferiority margins used in EVT device trials have regularly exceeded the MCIDs determined by stroke experts, as well as margins used for cardiac devices.
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10.1016/j.surg.2018.09.010
Conclusion: The overall reporting quality in randomized controlled trials of therapeutic medical device trials is suboptimal, particularly in terms of items regarding surgeons and hospitals.
Conclusion: The overall reporting quality in randomized controlled trials of therapeutic medical device trials is suboptimal, particularly in terms of items regarding surgeons and hospitals.
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10.1007/978-3-030-15310-6_13
Non-inferiority trials are commonly seen in medical device trials.
Non-inferiority trials are commonly seen in medical device trials.
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10.1136/bmjopen-2019-030139
Setting Being aware of the pitfalls associated with previous medical device trials, we developed a training programme to improve CPFA use (especially clotting problems).
Setting Being aware of the pitfalls associated with previous medical device trials, we developed a training programme to improve CPFA use (especially clotting problems).
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10.1016/j.cct.2019.06.009
The authors conducted a systematic review of high-risk trials, defined as randomized medication or device trials that specifically recruited individuals with psychotic disorders, to understand the use of capacity to consent assessment and their reporting.
The authors conducted a systematic review of high-risk trials, defined as randomized medication or device trials that specifically recruited individuals with psychotic disorders, to understand the use of capacity to consent assessment and their reporting.
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10.1177/1358863X19853623
This focus on vessel patency in clinical practice parallels the design of peripheral device trials, in which vessel patency is almost always the primary endpoint.
This focus on vessel patency in clinical practice parallels the design of peripheral device trials, in which vessel patency is almost always the primary endpoint.
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Keywords related to Device
Device Selection
Device Optimization
Device Performance
Device Voltage
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