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NCT Number: NCT07583225

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

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study 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

Acronym: HPSR-TCUS Clip

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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