Intracranial AneurysmsHPSR-TCUS ClipNCT07583225
Prospective Study of High-penetration Super-resolution Transcranial Ultrasound for Early Identification of Postoperative Intracranial Metallic Targets After Aneurysm Clipping
An observational study of Intracranial Aneurysms, run by Chinese PLA General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracranial Aneurysms
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 30 Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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;
- Written informed consent from the participant or legally authorized representative.
Who cannot join
- 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;
- Withdrawal of consent;
- Investigator judgment that continued participation is inappropriate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Intracranial Aneurysms
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Positive group | Metallic-clip model group | |
| Negative control group | Negative postoperative control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-level sensitivity for identifying the presence or absence of intracranial metallic targets
Measured: 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
Measured: Within 24 hours after surgery upon completion of composite reference standard adjudication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cong Feng, Chinese PLA General Hospital
- Investigators
- Feng, Principal investigator, PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583225
- Sponsor's protocol ID
- S2026-078-01
- Acronym
- HPSR-TCUS Clip
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07583225
- Acronym / sponsor ID
- HPSR-TCUS Clip / S2026-078-01
- Conditions
- Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive group | – | –Metallic-clip model group |
| Negative control group | – | –Negative postoperative control group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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;
- Written informed consent from the participant or legally authorized representative.
Key exclusion criteria (6 listed)
- 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;
- Withdrawal of consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng principal investigator
PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cao (+8601066937166, fc194@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.