UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020789 |
|---|---|
| Receipt number | R000024001 |
| Scientific Title | Development of clinical Magnetic Resonance Imaging techniques using high field magnetic resonance in endometriosis |
| Date of disclosure of the study information | 2016/01/29 |
| Last modified on | 2016/02/04 14:29:10 |
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Basic information
Public title
Development of clinical Magnetic Resonance Imaging techniques using high field magnetic resonance in endometriosis
Acronym
Clinical MRI technique development in endometriosis
Scientific Title
Development of clinical Magnetic Resonance Imaging techniques using high field magnetic resonance in endometriosis
Scientific Title:Acronym
Clinical MRI technique development in endometriosis
Region
| Japan |
Condition
Condition
endometriosis
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate uterine peristalsis during endoscopic therapy by a newly developed 3T-MR machine in patients with endometriosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic capability of a new acquisition method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
taking MR imaging
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
Female
Key inclusion criteria
Patients with endometriosis undergoing elective endoscopic surgery
Key exclusion criteria
Contraindication of MRI scan
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Togashi |
Organization
Kyoto University Hospital
Division name
Diagnostic radiology and nuclear medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto
TEL
075-751-3760
ktogashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aki KIDO |
Organization
Kyoto University Hospital
Division name
Diagnostic radiology and nuclear medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto
TEL
075-751-3760
Homepage URL
akikido@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Toshiba medical Systems Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 29 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 29 | Day |
Last modified on
| 2016 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024001
