UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035326
Receipt number 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 16:31:25

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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 or person

Institute

Niigata University

Institute

Department

Personal name



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

Value
https://center6.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