UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021620 |
|---|---|
| Receipt number | R000024933 |
| Scientific Title | A preliminary study on efficacy of Automated Breast Ultrasound System |
| Date of disclosure of the study information | 2016/03/26 |
| Last modified on | 2016/03/30 18:17:30 |
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Basic information
Public title
A preliminary study on efficacy of Automated Breast Ultrasound System
Acronym
utomated Breast Ultrasound System Study
Scientific Title
A preliminary study on efficacy of Automated Breast Ultrasound System
Scientific Title:Acronym
utomated Breast Ultrasound System Study
Region
| Japan |
Condition
Condition
Breast disease
Classification by specialty
| Breast surgery | Radiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
his study was to assess the broad utility of Automated Breast Ultrasound System.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detectability of breast lesion,
False-positive rate
Key secondary outcomes
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
one day
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
Patients who have breast lesion including fibroadenoma, breast cancer
Patients who have scar in the breasts after breast conserving surgery for breast cancer
Patients who have silicone implants
Patients who are during neoadjuvant chemotherapy or endocrine therapy
Patients who are in lactation period
and so on
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yagata |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Breast Care
Zip code
Address
1981, Kamoda, Kawagoe-shi, Saitama
TEL
049-228-3710
yagata@biglobe.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yagata |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Breast Care
Zip code
Address
1981, Kamoda, Kawagoe-shi, Saitama
TEL
049-228-3710
Homepage URL
yagata@biglobe.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
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
Address
Tel
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
| 2016 | Year | 03 | Month | 26 | 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
| 2016 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 26 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024933
