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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017421
Receipt No. 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

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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
Email 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
Email nakg_neurosurg@yahoo.co.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020204

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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