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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035326
Receipt No. R000040127
Scientific Title Study about the utility of the breast reconstruction utilizing the breast implant combined with the nipple areola reconstruction using the autologous tissue for amastia
Date of disclosure of the study information 2018/12/20
Last modified on 2018/12/20

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Basic information
Public title Study about the utility of the breast reconstruction utilizing the breast implant combined with the nipple areola reconstruction using the autologous tissue
for amastia
Acronym Amastia treatment by the implant and the nipple areola reconstruction using the autologous tissue
Scientific Title Study about the utility of the breast reconstruction utilizing the breast implant combined with the nipple areola reconstruction using the autologous tissue
for amastia
Scientific Title:Acronym Amastia treatment by the implant and the nipple areola reconstruction using the autologous tissue
Region
Japan

Condition
Condition Amastia
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To show that the breast reconstruction utilizing the breast implant and the nipple areola rebuilding using the autologous tissue are useful for amastia treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Is plasty of the natural and symmetrical
breast obtained at six months after surgery?
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 NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The breast plasty using the implant for the augmentation mammaplasty and the nipple areola plasty using the autologous tissue for amastia.Approximately six months
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 Female
Key inclusion criteria Amastia
Key exclusion criteria The patients who do not expect reconstruction.
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr.Masayuki Miyata
Organization Niigata University Medical and Dental Hospital
Division name Division of Plastic surgery
Zip code
Address 1-754, Asahimachidoori, Cyuoku, Niigata
TEL 025-227-2592
Email masamiya@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dr.Masayuki Miyata
Organization Niigata University Medical and Dental Hospital
Division name Division of Plastic surgery
Zip code
Address 1-754, Asahimachidoori, Cyuoku, Niigata
TEL 025-227-2592
Homepage URL
Email masamiya@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Niigata University
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
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
2018 Year 12 Month 20 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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 22 Day
Last follow-up date
2019 Year 03 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
2018 Year 12 Month 20 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040127

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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