UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017421 |
|---|---|
| Receipt number | R000020204 |
| Scientific Title | Experimental applica tion of piezo-driven pulsed water jet in neurosurgical specimen: Effectiveness and safety. |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2015/05/05 23:41:03 |
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Basic information
Public title
Experimental applica tion of piezo-driven pulsed water jet in neurosurgical specimen: Effectiveness and safety.
Acronym
Experimental application of piezo-driven pulsed water jet in neurosurgical specimen
Scientific Title
Experimental applica tion of piezo-driven pulsed water jet in neurosurgical specimen: Effectiveness and safety.
Scientific Title:Acronym
Experimental application of piezo-driven pulsed water jet in neurosurgical specimen
Region
| Japan |
Condition
Condition
Brain tumor (malignant tumor / benigh tumor), epilepsy, intracranial hemorrahge and trauma and spinal cord tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the material properties of central nervous system the apply the pizo-driven pulsed water jet in neurosurgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate penetration depth less than 3 mm at 0-100V at rate of 0-10 mm/sec
Key secondary outcomes
Evaluat e penetration depth less than 3 mm and evaluate effect on brain parenchyma, arachnoid membrane, blood vessel.
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
Treatment in Tohoku University Hospital / Standard surgical indication. No change in extent of removal of tissue due to sample obtaining.
Key exclusion criteria
Could not acuire informed consent / When the principal investigator considered not suitable.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teiji Tominaga |
Organization
Tohoku University Hospital
Division name
Department of Neurosurgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574 JAPAN
TEL
022-717-7230
tomi@nsg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Nakagawa |
Organization
Tohoku University Hospital
Division name
Deparment of Neurosurgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574 JAPAN
TEL
022-717-7230
Homepage URL
nakg_neurosurg@yahoo.co.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Translational Research Network Program
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
SEIKO EPSON CORPORATION
Name of secondary funder(s)
SEIKO-EPSON CORPORATION Tohoku University Collaborative Research Agreement
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
| 2015 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
Under investigation
Management information
Registered date
| 2015 | Year | 05 | Month | 05 | Day |
Last modified on
| 2015 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020204
