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Clinical Trials in China / NCT06642532
Recruiting Observational

A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty

NCT06642532 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Observational
Started
2024-06-01
Last updated
2024-11-15

Condition(s) studied

Cranial DefectTCD

Investigational drug(s) / intervention(s)

TCD group

TCD group: Transcranial Doppler ultrasound to examine bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window

Study summary

Polyetheretherketone has become one of the most important material choices for cranioplasty surgery. It has been shown that conventional ultrasound can be performed through the polyetheretherketone material for the examination of brain tissue and ventricular morphology. Transcranial doppler ultrasound can obtain good images of cerebral hemodynamic parameters in patients through polyetheretherketone-covered temporal window. This trial is a clinical prospective observational study in which cases treated with polyetheretherketone cranioplasty, and transcranial doppler ultrasonography is performed preoperatively and 10 days postoperatively, and data were collected mainly including bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age of 18 years or older; 2. Proposed polyetheretherketone cranioplasty; 3. Incomplete cranial bone in the lateral temporal window; 4. Signed informed consent for surgery and informed consent for research. Exclusion Criteria: 1)Although cranioplasty is proposed, the cranial bone in the temporal region is intact.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai Municipality Recruiting
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06642532 on ClinicalTrials.gov ↗ ← All trials in China