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Clinical Trials in Germany / NCT06798740
Recruiting Observational

Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices

NCT06798740 · tracked via the Priya Life Science Germany tracker
Sponsor
Mizuho Corporation
Phase
Observational
Started
2025-04-14
Last updated
2026-02-09

Condition(s) studied

Brain Aneurysm

Investigational drug(s) / intervention(s)

Sugita Titanium Aneurysm Clip II

Sugita Titanium Aneurysm Clip II: Aneurysm clipping is a surgical procedure used to treat brain aneurysms.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of permanent aneurysm occlusions — Up to 12 months
    Rate of complete permanent aneurysm occlusions according to Molyneux et al, 2005, where the category of occlusion is selected as "Complete occlusion".

Trial sites (1)

FacilityCityRegionStatus
Universitätsklinikum Essen Essen Germany Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06798740 on ClinicalTrials.gov ↗ ← All trials in Germany