UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058503 |
|---|---|
| Receipt number | R000066876 |
| Scientific Title | Assessing patient satisfaction following treatment with Transconjunctival Fat Removal. |
| Date of disclosure of the study information | 2025/07/17 |
| Last modified on | 2025/07/17 12:56:38 |
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Basic information
Public title
Assessing patient satisfaction following treatment with Transconjunctival Fat Removal.
Acronym
Assessing patient satisfaction following treatment with Transconjunctival Fat Removal.
Scientific Title
Assessing patient satisfaction following treatment with Transconjunctival Fat Removal.
Scientific Title:Acronym
Assessing patient satisfaction following treatment with Transconjunctival Fat Removal.
Region
| Japan |
Condition
Condition
Protrusion of orbital fat caused by orbital fat herniation, age-related lower eyelid fullness, or other degenerative changes.
Classification by specialty
| Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate patient satisfaction with transconjunctival fat removal performed for the correction of orbital fat protrusion resulting from orbital fat herniation, age-related lower eyelid bulging, and related conditions.
Treatment efficacy will be assessed through a prospective analysis based on patient data.
Basic objectives2
Others
Basic objectives -Others
A satisfaction survey will be conducted after the procedure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A patient satisfaction survey will be conducted one month after the start of treatment.
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who wish to undergo transconjunctival degreasing.
Patients who can give consent for the study.
Key exclusion criteria
Patients undergoing lower eyelid removal and fat injection.
Patients who have not given consent to participate in the study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
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@cybervision21.com
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Tamura |
Organization
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
Division name
Chief
Zip code
5300057
Address
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
TEL
06-6147-2581
Homepage URL
dr.tamura.takahiko@cybervision21.com
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch
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@medical-frontier.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 | 07 | Month | 17 | 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
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Cohort Study
Recruitment Period: August 2025 to January 2026 (scheduled)
Study Population: All patients who visit the participating medical institutions during the recruitment period and meet the inclusion criteria
Evaluation:
Patient-reported outcomes (satisfaction survey)
Presence of adverse events
Evaluation Schedule: Postoperative and 1 month after
Management information
Registered date
| 2025 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066876
