NCT04927156 Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
| NCT ID | NCT04927156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Balt Extrusion |
| Condition | Intracranial Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2021-07-12 |
| Primary Completion | 2041-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2021-07-12 with a primary completion date of 2041-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04927156 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04927156 currently recruiting?
Yes, NCT04927156 is actively recruiting participants. Contact the research team at Evidence@baltgroup.com for enrollment information.
Where is the NCT04927156 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, La Tronche, France, Lille, France and 8 additional locations.
Who is sponsoring the NCT04927156 clinical trial?
NCT04927156 is sponsored by Balt Extrusion. The trial plans to enroll 10,000 participants.