UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052166 |
|---|---|
| Receipt number | R000059534 |
| Scientific Title | Detection of dural defect localization using four-dimensional dynamic computed tomography myelography for patients with superficial siderosis |
| Date of disclosure of the study information | 2023/09/14 |
| Last modified on | 2025/03/12 11:14:10 |
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Basic information
Public title
Detection of dural defect localization using four-dimensional dynamic computed tomography myelography for patients with superficial siderosis
Acronym
Detection of dural defect localization using four-dimensional dynamic computed tomography myelography for patients with superficial siderosis
Scientific Title
Detection of dural defect localization using four-dimensional dynamic computed tomography myelography for patients with superficial siderosis
Scientific Title:Acronym
Detection of dural defect localization using four-dimensional dynamic computed tomography myelography for patients with superficial siderosis
Region
| Japan |
Condition
Condition
superficial siderosis
Classification by specialty
| Neurology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the Efficacy of 4D Dynamic CT Myelography in detedcting the Site of Dural Defects in Patients with superficial siderosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
With or without detecting of dural defect site
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Superficial siderosis patients with ventral fluid-filled collection in the spinal canal on MRI
Key exclusion criteria
Patients who did not give consent for testing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshitaka |
| Middle name | |
| Last name | Yoshii |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopedic Surgery
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo City, Tokyo, Japan
TEL
03-5803-5678
yoshii.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Toshitaka |
| Middle name | |
| Last name | Yoshii |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopedic Surgery
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo City, Tokyo, Japan
TEL
03-5803-5678
Homepage URL
yoshii.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics committee of Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo City, Tokyo 113-8510, Japan
Tel
03-3813-6111
Syomu1.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
03-3813-6111
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 14 | 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
17
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Detection of dural defect Sites on 4D Dynamic CTM in Patients with superficial siderosis on Retrospective Study
Management information
Registered date
| 2023 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059534
