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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033394
Receipt No. 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 2019/07/17

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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 Kazuhiro
Middle name
Last name Hongo
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
Institute Japan Agency for Medical Research and Development
Institute
Department

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
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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