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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
