UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017422
Receipt number 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 00:03:32

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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 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


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

Value
https://center6.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