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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorChinese PLA General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-85 years;

Positive group: patients undergoing intracranial aneurysm clipping with implanted metallic clips; negative control group: postoperative craniotomy patients without implanted clips;

Ability to complete transcranial ultrasound within 3 hours after surgery;

Availability of postoperative CT;

Disqualifiers

Inability to complete standardized transcranial ultrasound;

Missing postoperative CT;

Inability to establish the composite reference standard;

Presence of non-study-related metallic materials that may substantially interfere with target identification;

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

78 Participants
are grouped into 2 trial groups
Group A: Positive group
Group B: Negative control group

Trial outcomes

Primary outcomes

1

Patient-level sensitivity for identifying the presence or absence of intracranial metallic targets

Time frame
Within 24 hours after surgery upon completion of composite reference standard adjudication
2

Patient-level specificity for identifying the presence or absence of intracranial metallic targets

Time frame
Within 24 hours after surgery upon completion of composite reference standard adjudication

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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