Tracking outcomes after treating brain aneurysms with Sugita titanium clips
Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices
This registry will see how well Sugita titanium aneurysm clips work and how safe they are in adults treated for intracranial aneurysms during routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mizuho Corporation Academic / other |
| Locations | 1 site (Essen) |
| Trial ID | NCT06798740 on ClinicalTrials.gov |
What this trial studies
This observational post-market registry collects real-world data on adults who receive Sugita Titanium Aneurysm Clip II devices for intracranial aneurysms during routine neurosurgical care. Patients are enrolled when the treating physician intends to use the device and baseline, procedural, and follow-up information on device performance and complications are recorded. Participants are followed according to each hospital's standard of care for up to five years to capture long-term outcomes and potential risk factors. The aggregated data will support ongoing monitoring of device safety and performance in the European post-market environment.
Who should consider this trial
Good fit: Adults (≥18 years) with a ruptured or unruptured intracranial aneurysm that the treating neurosurgeon plans to treat with a Sugita clip and who can give informed consent and attend follow-up visits are ideal candidates.
Not a fit: Children under 18, patients who do not meet the device's instructions for use, those enrolled in other randomized device or drug trials, or those unable to complete follow-up are unlikely to benefit from this registry.
Why it matters
Potential benefit: If successful, the registry could confirm the device's long-term safety profile and provide information to help surgeons choose clips with better expected outcomes.
How similar studies have performed: Surgical clipping with titanium aneurysm clips is a long-established approach and prior registries and clinical experience generally support its safety, although device-specific post-market data are somewhat limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Essen
- Universitätsklinikum Essen — Essen, Germany (Recruiting)
Study contacts
- Study coordinator: Mai Hamayoshi
- Email: m.hamayoshi@mizuho.co.jp
- Phone: +81-3-3815-3180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.