UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000033394
Receipt number R000038073
Scientific Title Neurosurgery with middleware which enables integration of intraoperative information from each medical instrument
Date of disclosure of the study information 2018/07/17
Last modified on 2020/01/17 10:18:25

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Basic information

Public title

Neurosurgery with middleware which enables integration of intraoperative information from each medical instrument

Acronym

Neurosurgery with middleware which enables integration of intraoperative information

Scientific Title

Neurosurgery with middleware which enables integration of intraoperative information from each medical instrument

Scientific Title:Acronym

Neurosurgery with middleware which enables integration of intraoperative information

Region

Japan


Condition

Condition

brain tumor

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The narrative objects is to validate the safety and efficacy of the surgery with middleware "OPeLiNK" which enables integration of intraoperative information from various medical instrument.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Questionnaire from user of "OPeLiNK"

Key secondary outcomes

Postoperative neurological deficits, postoperative bleeding, complication of craniotomy such as infection


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Surgery using "OPeLiNK"

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who are equal or over 16 years old
2. Patients whose preoperative diagnosis are primary or metastatic brain tumor
3. Patients who agree with this clinical study
4. Patients who do not need agreement individually and who do not reject this clinical study

Key exclusion criteria

1. Patients who can not take MRI
2. Patients with severe heart, renal, hepatic disorder
3. Patients who have huge tumor
4. Patients who have deep-seated tumor
5. Patients who can not agree because of aphasia
6. Patients who had received chemoradiotherapy
7. Patients who have another malignant disease
8. Patients who are judged to be inappropriate in this clinical study

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Tetsuyoshi
Middle name
Last name Horiuchi

Organization

Shinshu University School of Medicine

Division name

Department of Neurosurgery

Zip code

390-8621

Address

Asahi 3-1-1, Matsumoto, Nagano

TEL

0263372690

Email

yufujii@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Yu
Middle name
Last name Fujii

Organization

Shinshu University School of Medicine

Division name

Department of Neurosurgery

Zip code

390-8621

Address

Asahi 3-1-1, Matsumoto, Nagano

TEL

0263372690

Homepage URL


Email

yufujii@shinshu-u.ac.jp


Sponsor or person

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Committee for Medical Ethics of Shinshu University School of Medicine

Address

Asahi 3-1-1, Matsumoto, Nagano

Tel

0263372572

Email

byouin_soumu@gm.shinshu-u.ac.jp


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

2018 Year 07 Month 17 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

2018 Year 06 Month 04 Day

Date of IRB

2018 Year 06 Month 06 Day

Anticipated trial start date

2018 Year 07 Month 17 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 15 Day

Last modified on

2020 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038073


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name