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

November 13, 2024 updated by: Junfeng Feng, RenJi Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
          • Junfeng Feng
          • Phone Number: +8613611860825
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Contact:
        • Contact:
          • Qing Mao, MD, PhD
        • Contact:
          • Junfeng Feng, MD, PhD
        • Contact:
          • Ru Gong, MD
        • Contact:
          • Jiyuan Hui, MD
        • Contact:
          • Ke Cao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  1. Age of 18 years or older;
  2. Proposed polyetheretherketone cranioplasty;
  3. Incomplete cranial bone in the lateral temporal window.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
transcranial doppler ultrasonography parameters before and after cranioplasty
Time Frame: 6 months
transcranial doppler ultrasonography's hemodynamic parameters: Pulse Index（PI） of middle cerebral artery(MCA), terminal internal carotid artery(TICA), anterior communicating artery(ACA), and posterior cerebral artery(PCA) from bilateral temporal window before and after polyetheretherketone cranioplasty. PI=（Vs - Vd ）/ Vm。
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 13, 2024

First Submitted That Met QC Criteria

October 13, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LY2024-093-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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