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To evaluate the patient-level early diagnostic performance of high-penetration super-resolution transcranial ultrasound for identifying intracranial metallic targets, and to further assess clip-level detection, localization, agreement, and its complementary value to routine postoperative imaging.This study does not alter routine clinical treatment. All participants will undergo standardized high-penetration super-resolution transcranial ultrasound within 3 hours after surgery. Postoperative CT is mandatory for all participants; CTA or other routine postoperative imaging will be obtained only when clinically indicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive group | Metallic-clip model group | ||
| Negative control group | Negative postoperative control group |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient-level sensitivity for identifying the presence or absence of intracranial metallic targets | Within 24 hours after surgery upon completion of composite reference standard adjudication | |
| Patient-level specificity for identifying the presence or absence of intracranial metallic targets | Within 24 hours after surgery upon completion of composite reference standard adjudication |
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Inclusion Criteria:
Exclusion Criteria:
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Positive group: standardized high-penetration super-resolution transcranial ultrasound within 3 hours after surgery, plus routine postoperative CT and CTA/other routine imaging when clinically indicated.
Negative control group: standardized high-penetration super-resolution transcranial ultrasound within 3 hours after surgery, plus routine postoperative CT.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cao | Contact | +8601066937166 | fc194@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng | PLA General Hospital | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 5, 2026 |
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| May 7, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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