Tracking outcomes after treating brain aneurysms with Sugita titanium clips

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Universitätsklinikum Essen
  Essen, Germany Recruiting

Study contacts

• Study coordinator: Mai Hamayoshi
• Email: m.hamayoshi@mizuho.co.jp
• Phone: +81-3-3815-3180

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.