UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025435
Receipt number R000029275
Scientific Title A study of sagged breast lifting using spring-shaped nylon threads.
Date of disclosure of the study information 2017/01/01
Last modified on 2019/12/30 11:46:33

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Basic information

Public title

A study of sagged breast lifting using spring-shaped nylon threads.

Acronym

Sagged breast lifting by spring threads.

Scientific Title

A study of sagged breast lifting using spring-shaped nylon threads.

Scientific Title:Acronym

Sagged breast lifting by spring threads.

Region

Japan


Condition

Condition

Sagged breast

Classification by specialty

Breast surgery Aesthetic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Esthetic improvement of the sagged breast due to aging by inserting spring-shaped Nylon threads.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement of saggings

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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

insertion of the spring-shaped nylon threads

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

50 years-old <=

Age-upper limit

65 years-old >=

Gender

Female

Key inclusion criteria

Individuals who like to improve the sagging of breasts and are diagnosed otherwise healthy by medical breast specialist

Key exclusion criteria

Pre-menopausal individuals,Individuals who were diagnosed as unhealthy by the breast examination

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Mototsugu
Middle name
Last name Fukaya

Organization

Tsurumai Kouen Clinic

Division name

director

Zip code

4600012

Address

5-20-6 Chiyoda Nakaku Nagoya

TEL

052-264-0212

Email

info@tclinic.jp


Public contact

Name of contact person

1st name Mototsugu
Middle name
Last name Fukaya

Organization

Tsurumai Kouen Clinic

Division name

director

Zip code

4600012

Address

5-20-6 Chiyoda Nakaku Nagoya

TEL

052-264-0212

Homepage URL


Email

info@tclinic.jp


Sponsor or person

Institute

Tsurumai Kouen Clinic

Institute

Department

Personal name



Funding Source

Organization

Tsurumai Kouen Clinic

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

Tsurumai Kouen Clinic

Address

5-20-6 CHIYODA NAKAKU NAGOYA

Tel

0522640212

Email

info@tclinic.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

2017 Year 01 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

2

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

Completed

Date of protocol fixation

2016 Year 12 Month 01 Day

Date of IRB

2016 Year 01 Month 01 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2019 Year 01 Month 01 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 12 Month 27 Day

Last modified on

2019 Year 12 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029275


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name