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.
Study Type
OBSERVATIONAL
Enrollment
10,000
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
CHU Angers
Angers, France
RECRUITINGChu Bordeaux
Bordeaux, France
RECRUITINGCHU Grenoble Alpes
La Tronche, France
RECRUITINGHôpital Roger Salengro
Lille, France
RECRUITINGKremlin Bicêtre - APHP
Paris, France
RECRUITINGChu Tours
Tours, France
RECRUITINGHalle
Halle, Germany
RECRUITINGHospital: Fundacion Jimenez Diaz
Madrid, Spain
RECRUITINGHospital Clinico Universitario San Carlos
Madrid, Spain
TERMINATEDUnversitario Central de Asturias
Oviedo, Spain
RECRUITING...and 2 more locations
Rate of occurrence of device-specific safety indicator(s).
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Time frame: From the procedure to 12 months post-procedure depending on the device family.
Rate of devices achieving its intended use.
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Time frame: From the procedure to 12 months post-procedure depending on the device family.
Rate of devices achieving its specific performance indicator(s).
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Time frame: 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
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.
Time frame: From the procedure to 12 months post-procedure depending on the device family.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.