UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059667 |
|---|---|
| Receipt number | R000068251 |
| Scientific Title | Development of a Preoperative Regression Model for Predicting Submental Liposuction Volume Using Outpatient-Accessible Measures: A Single-Center Prospective Observational Pilot Study |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/06 16:50:48 |
* 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
Development of a Preoperative Regression Model for Predicting Submental Liposuction Volume Using Outpatient-Accessible Measures: A Single-Center Prospective Observational Pilot Study
Acronym
Development of a Preoperative Regression Model for Predicting Submental Liposuction Volume Using Outpatient-Accessible Measures: A Single-Center Prospective Observational Pilot Study
Scientific Title
Development of a Preoperative Regression Model for Predicting Submental Liposuction Volume Using Outpatient-Accessible Measures: A Single-Center Prospective Observational Pilot Study
Scientific Title:Acronym
Development of a Preoperative Regression Model for Predicting Submental Liposuction Volume Using Outpatient-Accessible Measures: A Single-Center Prospective Observational Pilot Study
Region
| Japan |
Condition
Condition
Adult patients undergoing submental liposuction using the syringe technique at the participating institution.
Classification by specialty
| Plastic surgery | Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop and prospectively validate a regression formula that predicts submental liposuction volume (syringe technique) using simple outpatient-accessible measures (vertical length, skinfold thickness, BMI, and tissue firmness).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between measured liposuction volume (mL) and predicted value (mL) calculated from the regression model, assessed by Pearson's correlation coefficient and coefficient of determination.
Key secondary outcomes
Univariate correlations between each variable (thickness, vertical length, BMI, firmness) and aspirated volume
Independent contributions of predictors in the multivariate regression model (standardized beta coefficients)
Reproducibility of each measurement (intra-rater reliability, ICC)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who wish to undergo submental liposuction with the syringe technique
Provided written informed consent for participation
Eligible for preoperative outpatient evaluation
Key exclusion criteria
History of previous surgery or trauma in the submental region
Severe neck skin laxity or scar contracture
Presence of dermatologic conditions that interfere with measurement accuracy
Declined to provide informed consent
Target sample size
60
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
Director
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 | Keisuke |
| Middle name | |
| Last name | Matsumura |
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.matsumura.keisuke@tcb.or.jp
Sponsor or person
Institute
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
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 | 11 | Month | 07 | 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 | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | 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, prospective observational (non-interventional) study.
Preoperative morphometric parameters will be measured in patients undergoing submental liposuction, and the predicted liposuction volume will be compared with the actual aspirated volume to validate the regression model.
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068251
