UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009613 |
|---|---|
| Receipt number | R000011276 |
| Scientific Title | A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Essential Tremor |
| Date of disclosure of the study information | 2012/12/27 |
| Last modified on | 2018/12/27 09:36:46 |
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Basic information
Public title
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Essential Tremor
Acronym
Treatment of essential tremor with focused ultrasound
Scientific Title
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Essential Tremor
Scientific Title:Acronym
Treatment of essential tremor with focused ultrasound
Region
| Japan |
Condition
Condition
essential tremor
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Essential Tremor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tremor improvement and evaluation of advers effect 3 months after treatment
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Focused untrasound
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
| 22 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
intractable to medical treatment
Key exclusion criteria
not suitable for surgical intervention due to bleeding tendency etc
previous intracranial operation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaomi Taira |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery
Zip code
Address
8-1 Kawada, Shinjuku, Tokyo 1628666, Japan
TEL
03-3353-81111
ttaira@nij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaomi Taira |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery
Zip code
Address
8-1 Kawada, Shinjuku, Tokyo 1628666, Japan
TEL
0333538111
Homepage URL
ttaira@nij.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Shin-yurigaoka general hospital
Institute
Department
Personal name
Funding Source
Organization
Insightec
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
ET001J
Org. issuing International ID_1
Insightec
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 | 12 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 22 | Day |
Last modified on
| 2018 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011276
