Prospective Study of High-penetration Super-resolution Transcranial Ultrasound for Early Identification of Postoperative Intracranial Metallic Targets After Aneurysm Clipping

Clinical Model-Based Evaluation of High-Penetration Super-Resolution Transcranial Ultrasound for Early Diagnosis of Intracranial Metallic Foreign Bodies in Patients After Intracranial Aneurysm Clipping

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07583225

Acronym

HPSR-TCUS Clip

Enrollment

Registered

2026-05-13

Start date

2026-05-30

Completion date

2027-04-30

Last updated

2026-05-15

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

Conditions

Intracranial Aneurysms

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Inclusion criteria

1. Age 18-85 years; 2. Positive group: patients undergoing intracranial aneurysm clipping with implanted metallic clips; negative control group: postoperative craniotomy patients without implanted clips; 3. Ability to complete transcranial ultrasound within 3 hours after surgery; 4. Availability of postoperative CT; 5. Written informed consent from the participant or legally authorized representative.

Exclusion criteria

1. Inability to complete standardized transcranial ultrasound; 2. Missing postoperative CT; 3. Inability to establish the composite reference standard; 4. Presence of non-study-related metallic materials that may substantially interfere with target identification; 5. Withdrawal of consent; 6. Investigator judgment that continued participation is inappropriate.

Design outcomes

Primary

Measure	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

Contacts

CONTACTCao

fc194@163.com+8601066937166

PRINCIPAL_INVESTIGATORFeng

PLA General Hospital

Outcome results