UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059561 |
|---|---|
| Receipt number | R000068100 |
| Scientific Title | Objective Early Volumetric Retention after Forehead Fat Grafting Quantified with 3D Stereophotogrammetry: A Pilot Study. |
| Date of disclosure of the study information | 2025/10/28 |
| Last modified on | 2025/10/28 09:27:35 |
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Basic information
Public title
Objective Early Volumetric Retention after Forehead Fat Grafting Quantified with 3D Stereophotogrammetry: A Pilot Study.
Acronym
Objective Early Volumetric Retention after Forehead Fat Grafting Quantified with 3D Stereophotogrammetry: A Pilot Study.
Scientific Title
Objective Early Volumetric Retention after Forehead Fat Grafting Quantified with 3D Stereophotogrammetry: A Pilot Study.
Scientific Title:Acronym
Objective Early Volumetric Retention after Forehead Fat Grafting Quantified with 3D Stereophotogrammetry: A Pilot Study.
Region
| Japan |
Condition
Condition
Skin tissue exhibiting atrophy or deformity caused by aging, trauma, or congenital abnormalities.
Classification by specialty
| Dermatology | Plastic surgery | Aesthetic surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To objectively quantify early fat graft survival after autologous forehead fat grafting and to validate the utility of handheld 3D stereophotogrammetry as a reproducible clinical measurement workflow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: Fat graft survival rate (%) at 1 month
Formula: (1-month volume / immediate postoperative volume) x 100
Key secondary outcomes
Fat graft survival rate at 2 weeks.
Correlation between injected and immediately measured 3D volumes (r value).
Incidence of adverse events.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Adult female patients who underwent forehead fat grafting for aesthetic augmentation.
Provided written informed consent for participation and imaging.
Completed all 3D imaging sessions (preoperative, immediate postoperative, 2 weeks, 1 month).
Key exclusion criteria
Prior forehead fat grafting.
Active local skin disease or infection.
Inability to complete serial follow-up imaging.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
umeda.office@tcb.or.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Furuichi |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
Homepage URL
dr.furuichi.yoshimasa@tcb.or.jp
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
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
TCB Academic Committee and IRB
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
Tel
06-6147-2581
irb@tcb.or.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
| 2025 | Year | 10 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center pilot observational study.
Prospectively standardized imaging workflow with retrospective volumetric analysis.
Management information
Registered date
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068100
