UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054646 |
|---|---|
| Receipt number | R000062445 |
| Scientific Title | Post Market Registry Study of Intracranial Aneurysms Treated with Sugita clip. |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/12/13 09:05:45 |
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Basic information
Public title
Post Market Registry Study of Intracranial Aneurysms Treated with Sugita clip.
Acronym
Post Market Registry Study of Intracranial Aneurysms Treated with Sugita clip.
Scientific Title
Post Market Registry Study of Intracranial Aneurysms Treated with Sugita clip.
Scientific Title:Acronym
Post Market Registry Study of Intracranial Aneurysms Treated with Sugita clip.
Region
| Japan |
Condition
Condition
intracranial aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the performance and safety of Sugita clipping device when implanted in the body for an extended period of time in patients who have undergone intracranial aneurysm clipping using the Sugita clipping device, and to identify possible risk factors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Complete occlusion rate of intracranial aneurysms treated with the Sugita clipping device at 12 months postoperatively
Key secondary outcomes
(1) Evaluation of failure and adverse events up to 60 months postoperatively
(2) Comparison of preoperative mRS and mRS up to 60 months postoperatively
(3) Comparison of preoperative HK and WFNS classification and postoperative mRS for ruptured intracranial aneurysms
(4) Reoperation rate of subject aneurysms up to 60 months postoperatively
(5) Surgical success rate: Complete occlusion rate of cerebral aneurysms within 1 week after surgery Completely occluded rate of cerebral aneurysm within 1 week after surgery
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients (regardless of age and gender) with ruptured or unruptured cerebral aneurysms that can be treated by cerebral aneurysm clipping using this device
(2) Patients who have obtained written consent to participate in this study from the subject or a substitute
(3) Patients who are willing to continue scheduled examinations and tests according to institutional standard of care (3) Patients who are willing to continue scheduled examinations and tests in accordance with institutional standard of care.
Key exclusion criteria
(1) Patients who are participating or will participate in a randomized trial of another drug or device
(2) Patients who are unable to undergo follow-up after cerebral aneurysm clipping according to the standard of care at the study site (e.g., medical condition or overseas residency and inability to return home for follow-up)
(3) Patients who do not meet the Instructions for Use (IFU) criteria for this device:
- Patients with severe allergies to metals or relics
- Patients with infections that may lead to metastasis of infected lesions or septicemia
Target sample size
169
Research contact person
Name of lead principal investigator
| 1st name | Saito |
| Middle name | |
| Last name | Ryuta |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
466-8560
Address
Tsurumai-cho 65, SHowa-ku, Nagoya, Aichi
TEL
052-744-2353
ryuta@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Gotoh |
| Middle name | |
| Last name | Shunsaku |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
466-8560
Address
Tsurumai-cho 65, SHowa-ku, Nagoya, Aichi
TEL
052-744-2353
Homepage URL
saku.y.1210@gmail.com
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
MIZUHO Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Clinical Research Review Committee
Address
Tsurumai-cho 65, Showa-ku, Nagoya, Aichi
Tel
052-744-2423
iga-shinsa@t.mail.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2032 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2032 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2032 | Year | 12 | Month | 31 | Day |
Other
Other related information
Study subjects will be enrolled from the date of surgery until one week before the postoperative examination. The study will be defined as complete when the last enrolled study subject completes the 5-year follow-up examination.
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062445
