Brain Aneurysm Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Universitätsklinikum Essen
RECRUITING
Essen
Contact Information
Primary
Mai Hamayoshi
m.hamayoshi@mizuho.co.jp
+81-3-3815-3180
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2033-02-14
Participants
Target number of participants: 150
Treatments
Aneurysm clip
Patients presenting intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the Sugita clips.
Related Therapeutic Areas
Sponsors
Leads: Mizuho Corporation

This content was sourced from clinicaltrials.gov