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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023928
Receipt No. R000027553
Scientific Title Study on the efficacy and sfety of breast diagnostic imaging equipment (microwave scattered field tomographic imaging machine-a)
Date of disclosure of the study information 2016/10/01
Last modified on 2019/01/25

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Basic information
Public title Study on the efficacy and sfety of breast diagnostic imaging equipment (microwave scattered field tomographic imaging machine-a)
Acronym Clinical investigation of microwave mammography
Scientific Title Study on the efficacy and sfety of breast diagnostic imaging equipment (microwave scattered field tomographic imaging machine-a)
Scientific Title:Acronym Clinical investigation of microwave mammography
Region
Japan

Condition
Condition brest cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigate the efficacy and safety of a new non-invasive imaging diagnostic equipment using microwave.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluating the efficacy of images obtained by new diagnostic equipment using microwave
Key secondary outcomes Evaluating the safety of the new diagnostic equipment using microwave

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Put the UWB(ultra wide band) sensor on the surface of the breast and then the wave is transmitted and received. The data is analyzed and image is built by the computer.
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 Ipsilateral and contralateral breast of breast cancer patient.
Both breast of healthy person.
Key exclusion criteria Patients who do not agree with this study.
Patients who were deemed inappropriate by the attending physician.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonari Kunihisa
Organization Kobe university hospital
Division name Breast Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo-Prefecture
TEL 078-382-6871
Email tkunihisa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomonari Kunihisa
Organization Kobe university hospital
Division name Breast Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo-Prefecture
TEL 078-382-6871
Homepage URL
Email tkunihisa@gmail.com

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 神戸大学医学部附属病院(兵庫県)(Kobe university hospital, Hyogo), 兵庫県立がんセンタ-(兵庫県)(Hyogo cancer center, Hyogo), ときわ病院(兵庫県)(Tokiwa Hospital, Hyogo),岡本クリニック(兵庫県)(Okamoto Clinic, Hyogo)

Other administrative information
Date of disclosure of the study information
2016 Year 10 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 04 Day
Last modified on
2019 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027553

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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