BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices. This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Rate of occurrence of device-specific safety indicator(s).
Timeframe: From the procedure to 12 months post-procedure depending on the device family.
Rate of devices achieving its intended use.
Timeframe: From the procedure to 12 months post-procedure depending on the device family.
Rate of devices achieving its specific performance indicator(s).
Timeframe: From the procedure to 12 months post-procedure depending on the device family.
Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator
Timeframe: From the procedure to 12 months post-procedure depending on the device family.