Post Market Registry Study of Intracranial Aneurysms Treated with Sugita clip.

Post Market Registry Study of Intracranial Aneurysms Treated with Sugita clip. - Post Market Registry Study of Intracranial Aneurysms Treated with Sugita clip.

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054646

Enrollment

169

Registered

2024-10-01

Start date

2024-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracranial aneurysm

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Complete occlusion rate of intracranial aneurysms treated with the Sugita clipping device at 12 months postoperatively	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

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Countries

Japan

Contacts

Public ContactGotoh Shunsaku

Nagoya University Graduate School of Medicine Department of Neurosurgery

saku.y.1210@gmail.com052-744-2353

Outcome results