NCT06798740 Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices
| NCT ID | NCT06798740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mizuho Corporation |
| Condition | Brain Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2027-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
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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 150 participants in total. It began in 2025-04-14 with a primary completion date of 2027-02-14.
⚠ 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
The objective of this study is to verify the performance and safety of the Sugita Aneurysm Clips devices when used as intended and to identify possible risk factors. Data collected will be used to support the continuing performance and safety of the devices in the post-market use environment in Europe. Subjects who have an intracranial aneurysm that the physician intends to treat with the subject devices will be included in the study. Subjects will be followup as per hospital standard of care for 5 years.
Eligibility Criteria
Inclusion Criteria: * Subject has an intracranial aneurysm (ruptured or unruptured) that can be treated with one of the proposed devices. * Subject is adult, ≥18 years. * As per national regulations, subject or subject's legally authorized representative (LAR) has signed written informed consent. * Subject is willing to comply with scheduled visits and examinations per institutional standard of care. Exclusion Criteria: * Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device randomized study. * Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow- up, e.g.). * Subject does not meet IFU criteria of the subject device. * Subject is a child, \<18 years.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06798740 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06798740 currently recruiting?
Yes, NCT06798740 is actively recruiting participants. Contact the research team at m.hamayoshi@mizuho.co.jp for enrollment information.
Where is the NCT06798740 trial being conducted?
This trial is being conducted at Essen, Germany.
Who is sponsoring the NCT06798740 clinical trial?
NCT06798740 is sponsored by Mizuho Corporation. The trial plans to enroll 150 participants.