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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017422
Receipt No. R000020208
Scientific Title Application of high power piezo-driven pulsed water jet in neurosurgery
Date of disclosure of the study information 2015/06/01
Last modified on 2015/05/06

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Basic information
Public title Application of high power piezo-driven pulsed water jet in neurosurgery
Acronym Application of high power piezo-driven pulsed water jet in neurosurgery
Scientific Title Application of high power piezo-driven pulsed water jet in neurosurgery
Scientific Title:Acronym Application of high power piezo-driven pulsed water jet in neurosurgery
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 prove the safety of the high power 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 of safety in intraoperative finding / by psotoperative imaging / new neurological defici t
Key secondary outcomes Evaluate of safety, effica cy and usability in intraoperative finding / by psotoperative imaging / new neurological deficit

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 Surgery
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 65

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 04 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 06 Day
Last modified on
2015 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020208

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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