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

Launched by BALT EXTRUSION · Jun 14, 2021

Keywords

ClinConnect Summary

This clinical trial, called the EVIDENCE Post Marketing Clinical Follow-up Platform, is studying the safety and performance of medical devices developed by BALT for treating conditions related to the brain and blood vessels, such as aneurysms, strokes, and vascular diseases. The goal is to gather more information about how these devices work in real-world settings after they have been approved for use.

To participate in this trial, individuals aged 730 days and older can join if they provide signed consent, meaning they agree to take part in the study. However, if a participant has had a device used for multiple medical issues in one procedure or if there are specific medical reasons that prevent the use of the device, they cannot participate. Those who join can expect to contribute to important research that helps improve treatment options for these serious conditions, while also being monitored for the safety and effectiveness of the devices used.

Gender

ALL

Eligibility criteria

• 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.