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

NCT ID: NCT06798740

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-15

Study Completion Date

2033-02-14

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aneurysm clip

Patients presenting intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the Sugita clips.

Sugita Titanium Aneurysm Clip II

Intervention Type DEVICE

Aneurysm clipping is a surgical procedure used to treat brain aneurysms.

Interventions

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Sugita Titanium Aneurysm Clip II

Aneurysm clipping is a surgical procedure used to treat brain aneurysms.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mizuho Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum Essen

Essen, , Germany

Site Status

Countries

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Germany

Central Contacts

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Mai Hamayoshi

Role: CONTACT

+81-3-3815-3180

Facility Contacts

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Ulrich Sure, MD

Role: primary

+49 201 / 723-84208

Other Identifiers

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CE-0005_CIP

Identifier Type: -

Identifier Source: org_study_id

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