Brain AneurysmT2_PMCFNCT06798740
Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices
An observational study of Brain Aneurysm, run by Mizuho Corporation at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Aneurysm
- What is being tested?
- Sugita Titanium Aneurysm Clip II
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 14 Apr 2025to 14 Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have an intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the subject device(s)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Essen
Essen, D- 45122
Ulrich Sure, MD, +49 201 / 723-84208
About this study
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.
- Conditions
- Brain Aneurysm
- Being tested
- Sugita Titanium Aneurysm Clip II
- Keywords
- clip, sugita
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugita Titanium Aneurysm Clip IIDevice
Aneurysm clipping is a surgical procedure used to treat brain aneurysms.
| Study group | Role | What they receive |
|---|---|---|
| Aneurysm clip | Patients presenting intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the Sugita clips. Receives: Device: Sugita Titanium Aneurysm Clip II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of permanent aneurysm occlusions
Rate of complete permanent aneurysm occlusions according to Molyneux et al, 2005, where the category of occlusion is selected as "Complete occlusion".
Measured: Up to 12 months
Secondary outcomes (5)
Incidence of adverse events
The number and percentage of subjects experiencing any adverse event. Each adverse event type, including severity will be reported.
Measured: up to 60 months
Change in Modified Rankin Scale
The mean, standard deviation, median, minimum, maximum, and number of evaluable observations will be reported for baseline and to each follow up visit using descriptive statistics.The absolute change from baseline will be calculated for each subject at follow up visits.
Measured: through 60 months
Amount of aneurysm retreatments
The amount of aneurysm retreatments will be reported as 0, 1 and >=2 retreatments through each follow up visit.
Measured: through 60 months
Procedure success rate
Rate of successful aneurysm occlusions per Molyneux classification "Complete occlusion" while using a permanent clip. Frequency counts and percentages of subjects, as well as 95% confidence intervals for the percentages will be presented.
Measured: within 1 week after clipping
Rate of successful applications of temporary clips
Subjects that experience a successful aneurysm occlusion according to Molyneux classification "Complete occlusion" while using temporary clips.
Measured: Within 1 week after clipping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start14 Apr 2025
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mizuho Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798740
- Sponsor's protocol ID
- CE-0005_CIP
- Acronym
- T2_PMCF
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices
- ClinicalTrials.gov ID
- NCT06798740
- Acronym / sponsor ID
- T2_PMCF / CE-0005_CIP
- Conditions
- Brain Aneurysm
- Keywords
- clip, sugita
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mizuho CorporationUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Feb 2033 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aneurysm clip | – | Device: Sugita Titanium Aneurysm Clip IIPatients presenting intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the Sugita clips. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have an intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the subject device(s)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugita Titanium Aneurysm Clip IIAneurysm clipping is a surgical procedure used to treat brain aneurysms. | Device | Aneurysm clip |
Primary outcome
Rate of permanent aneurysm occlusions
Time frame: 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".
5 secondary outcomes
Incidence of adverse events
Time frame: up to 60 months
Change in Modified Rankin Scale
Time frame: through 60 months
Amount of aneurysm retreatments
Time frame: through 60 months
Procedure success rate
Time frame: within 1 week after clipping
Rate of successful applications of temporary clips
Time frame: Within 1 week after clipping
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Aneurysm, run by Mizuho Corporation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai Hamayoshi (+81-3-3815-3180, m.hamayoshi@mizuho.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of permanent aneurysm occlusions (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.