Cranial DefectNCT06642532
A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
An observational study of Cranial Defect and TCD, run by RenJi Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Defect, TCD
- What is being tested?
- TCD group
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Age of 18 years or older; 2. Proposed polyetheretherketone cranioplasty; 3. Incomplete cranial bone in the lateral temporal window.
Who may be able to join
- Age of 18 years or older;
- Proposed polyetheretherketone cranioplasty;
- Incomplete cranial bone in the lateral temporal window;
- Signed informed consent for surgery and informed consent for research.
Who cannot join
- 1)Although cranioplasty is proposed, the cranial bone in the temporal region is intact.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Junfeng Feng, MD, PhD, 86-21-68383707, fengjfmail@163.com
Yanqing Ni, MD, 86-21-68383707, pd120xz@126.com
- Recruiting
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Junfeng Feng, +8613611860825
About this study
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.
- Conditions
- Cranial Defect, TCD
- Being tested
- TCD group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCD groupDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
transcranial doppler ultrasonography parameters before and after cranioplasty
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。
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial DefectStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junfeng Feng, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642532
- Sponsor's protocol ID
- LY2024-093-B
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
- ClinicalTrials.gov ID
- NCT06642532
- Acronym / sponsor ID
- LY2024-093-B
- Conditions
- Cranial Defect, TCD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Oct 2024 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Age of 18 years or older; 2. Proposed polyetheretherketone cranioplasty; 3. Incomplete cranial bone in the lateral temporal window.
Key inclusion criteria (4 listed)
- Age of 18 years or older;
- Proposed polyetheretherketone cranioplasty;
- Incomplete cranial bone in the lateral temporal window;
- Signed informed consent for surgery and informed consent for research.
Key exclusion criteria (1 listed)
- 1)Although cranioplasty is proposed, the cranial bone in the temporal region is intact.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCD groupTranscranial 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 | Device | – |
Primary outcome
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。
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cranial Defect and TCD, run by RenJi Hospital at 2 sites in China.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junfeng Feng (13611860825, fengjfmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transcranial doppler ultrasonography parameters before and after cranioplasty (time frame: 6 months). 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 Nov 2024.