Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

Condition(s) studied

Investigational drug(s) / intervention(s)

BALT medical devices: Includes, but is not limited to, the following: * Access devices * Aneurysm treatment devices * Ischemic Stroke and peripheral occlusive diseases treatment devices * Arterio-Venous Malformations/fistulas treatment devices

Study summary

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.

Eligibility

Primary outcome measure(s)

• Rate of occurrence of device-specific safety indicator(s). — From the procedure to 12 months post-procedure depending on the device family.
  Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
• Rate of devices achieving its intended use. — From the procedure to 12 months post-procedure depending on the device family.
  Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
• Rate of devices achieving its specific performance indicator(s). — From the procedure to 12 months post-procedure depending on the device family.
  Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
• Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator — From the procedure to 12 months post-procedure depending on the device family.
  Qualitative measurement of usability for each usability indicator (i.e., good, well adapted, fairly adapted, bad). Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.

Trial sites (12)

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