UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021739 |
|---|---|
| Receipt number | R000025065 |
| Scientific Title | Evaluation of endoscopic microvascular decompression for trigeminal neuralgia and hemifacial spasm |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2017/12/11 15:15:39 |
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Basic information
Public title
Evaluation of endoscopic microvascular decompression for trigeminal neuralgia and hemifacial spasm
Acronym
Evaluation of endoscopic microvascular decompression
Scientific Title
Evaluation of endoscopic microvascular decompression for trigeminal neuralgia and hemifacial spasm
Scientific Title:Acronym
Evaluation of endoscopic microvascular decompression
Region
| Japan |
Condition
Condition
trigeminal neuralgia, hemifacial spasm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this study is to evaluate efficacy and safety of endoscopic microvascular decompression for trigeminal neuralgia and hemihfacial spasm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barrow Neurological Institute pain intensity score and Kondo score at 6 months later of surgery
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
| Maneuver |
Interventions/Control_1
Endoscopic microvascular decompression is performed.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Medical management have failed prior to surgery.
The patient hope to have surgical management.
Key exclusion criteria
General anesthesia is impossible.
Affected nerve is compressed by an aneurysm or an brain tumor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuminari Komatsu |
Organization
Tokai University Hachioji Hospital
Division name
Department of Neurosurgery
Zip code
Address
1838 Ishikawa-machi, Hachioji, Tokyo, Japan
TEL
042-639-1111
fuminarikomatsu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuminari Komatsu |
Organization
Tokai University Hachioji Hospital
Division name
Department of Neurosurgery
Zip code
Address
1838 Ishikawa-machi, Hachioji, Tokyo, Japan
TEL
042-639-1111
Homepage URL
fuminarikomatsu@gmail.com
Sponsor or person
Institute
Department of Neurosurgery, Tokai University School of Medicine, Kanagawa, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Tokai University School of Medicine, Kanagawa, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Neurosurgery, Tokai University School of Medicine, Kanagawa, Japan
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
東海大学医学部付属八王子病院
東海大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
| 2016 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2017 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025065
