UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053558 |
|---|---|
| Receipt number | R000060915 |
| Scientific Title | Ultrasound Elastography for Epileptic Focus in Epilepsy Surgery |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/03/04 15:53:02 |
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Basic information
Public title
Ultrasound Elastography for Epileptic Focus in Epilepsy Surgery
Acronym
not applicable
Scientific Title
Ultrasound Elastography for Epileptic Focus in Epilepsy Surgery
Scientific Title:Acronym
not applicable
Region
| Japan |
Condition
Condition
intractable epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the hardness of the epileptogenic cortex compared to the nonepileptic cortex using ultrasound elastography.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to explore the hardness of the epileptogenic cortex compared to the nonepileptic cortex using ultrasound elastography.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Seizure outcome at postoperative one year
Key secondary outcomes
not applicable
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
We will perform ultrasound elastography on the surface of the cortex intraoperatively in patients who undergo epilepsy surgery.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patients aged 18-65 who undergo focus resection under the diagnosis of intractable epilepsy.
2. Resection area is determined preoperatively.
3. Written informed consent is obtained.
4. Able to visit our hospital at postoperative one year.
Key exclusion criteria
1. previous craniotomy
2. risk of hemorrhagic complication
3. resection area not determined preoperatively
4. other factors principal investigator judged as dangerous
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Iida |
Organization
Hiroshima University Hospital
Division name
Epilepsy Center
Zip code
734-8551
Address
1-2-3 Kasumi, Hiroshima City, Japan
TEL
0822571719
iidak@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Kagawa |
Organization
Hiroshima University Hospital
Division name
Department of Neurosurgery
Zip code
734
Address
1-2-3 Kasumi, Hiroshima City, Japan
TEL
082-257-5227
Homepage URL
kotakgw@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060915
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
