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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04927156
Other study ID # CIP-202002-BALT DEVICES
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 12, 2021
Est. completion date October 2041

Study information

Verified date February 2023
Source Balt Extrusion
Contact Clinical Affairs Department
Phone +33 1 39 89 46 41
Email Evidence@baltgroup.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date October 2041
Est. primary completion date June 2041
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: - Provision of a signed, written and dated informed consent or non-opposition (where applicable) Exclusion Criteria - Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure) - Contra-indications of each device as described in the instructions for use.

Study Design


Intervention

Device:
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

Locations

Country Name City State
France CHU Angers Angers
France CHU Grenoble Alpes La Tronche
France Hôpital Roger Salengro Lille
France Chu Tours Tours
Spain Hospital Clinico Universitario San Carlos Madrid
Spain Hospital: Fundacion Jimenez Diaz Madrid
Spain Hospital: Puerta de Hierro Madrid
Spain Unversitario Central de Asturias Oviedo
Spain Hospital Universitario Marqués de Valdecilla (HUMV) Santander
Spain Hospital Universitario Miguel Servet Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Balt Extrusion

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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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