UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007542 |
|---|---|
| Receipt number | R000008892 |
| Scientific Title | Treatment for uterine myoma by MRgFUS |
| Date of disclosure of the study information | 2012/03/21 |
| Last modified on | 2012/03/19 19:44:22 |
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Basic information
Public title
Treatment for uterine myoma by MRgFUS
Acronym
MRgFUS treatment
Scientific Title
Treatment for uterine myoma by MRgFUS
Scientific Title:Acronym
MRgFUS treatment
Region
| Japan |
Condition
Condition
uterine myoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of treatment for uterine myoma by MRgFUS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptom and size of uterine myoma
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
MR guided focused ultrasound therapy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Possible for MRI examination
Applicable for MRgFUS
Key exclusion criteria
contraindication for MRI examination
non-applicable for MRgFUS
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Harada |
Organization
The University of Tokushima
Division name
Department of Radiology
Zip code
Address
3-18-15, Kuramoto-Cho, Tokushima City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Harada |
Organization
The University of Tokushima
Division name
Department of Radiology
Zip code
Address
3-18-15, Kuramoto-Cho, Tokushima city
TEL
Homepage URL
Sponsor or person
Institute
The University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 21 | Day |
Last modified on
| 2012 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008892
