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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BALT medical devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BALT medical devices | Device | Includes, but is not limited to, the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | From the procedure to 12 months post-procedure depending on the device family. |
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Inclusion Criteria:
Exclusion Criteria
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The study population will include the BALT medical devices under consideration used in their respective indications for use during interventions performed at the participating sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Department | Contact | +33 1 39 89 46 41 | Evidence@baltgroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Recruiting | Angers | France |
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| Chu Bordeaux | Recruiting | Bordeaux | France |
|
| CHU Grenoble Alpes | Recruiting | La Tronche | France |
|
| Hôpital Roger Salengro | Recruiting | Lille | France |
|
| Kremlin Bicêtre - APHP | Recruiting | Paris | France |
|
| Chu Tours | Recruiting | Tours | 37000 | France |
|
| Halle | Recruiting | Halle | Germany |
|
| Hospital: Fundacion Jimenez Diaz | Recruiting | Madrid | 28222 | Spain |
|
| Hospital Clinico Universitario San Carlos | Terminated | Madrid | Spain |
| Unversitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
|
| Hospital Universitario Marqués de Valdecilla (HUMV) | Recruiting | Santander | Spain |
|
| Hospital Universitario Miguel Servet | Not yet recruiting | Zaragoza | Spain |
|
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D020765 | Intracranial Arterial Diseases |
| D000083242 | Ischemic Stroke |
| D016491 | Peripheral Vascular Diseases |
| D002538 | Intracranial Arteriovenous Malformations |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020521 | Stroke |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016157 | Vascular Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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