UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062035 |
|---|---|
| Receipt number | R000070987 |
| Scientific Title | A Prospective Study to Establish a Volume Measurement Method Using Circumference Measurements and the Truncated Cone Method in Upper Extremity Lymphedema |
| Date of disclosure of the study information | 2026/06/23 |
| Last modified on | 2026/06/23 22:21:17 |
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Basic information
Public title
Prospective Study to Establish a Volume Measurement Method Using Circumference Measurements and the Truncated Cone Method in Upper Extremity Lymphedema
Acronym
UEL Volume Study
Scientific Title
A Prospective Study to Establish a Volume Measurement Method Using Circumference Measurements and the Truncated Cone Method in Upper Extremity Lymphedema
Scientific Title:Acronym
UEL Volume Study
Region
| Japan |
Condition
Condition
Upper Extremity Lymphedema
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the validity of upper limb volume measurements calculated using the truncated cone method based on circumference measurements by comparing them with Perometer-derived volumes in patients with upper extremity lymphedema, and to determine the optimal number of measurement points for practical clinical use.
Basic objectives2
Others
Basic objectives -Others
Validation of upper limb volume measurement using circumference measurements and the truncated cone method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between upper limb volume measured using the circumference-based truncated cone method and upper limb volume measured by the water displacement method
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 years or older receiving care at our institution.
Individuals who provide written informed consent for participation in this study.
Key exclusion criteria
Patients with upper extremity disorders other than lymphedema (e.g., skin ulcers, eczema, rash, or infection).
Patients unable to maintain a standing position.
Patients considered unsuitable for participation by the investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masak |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu University School of Medicine
Division name
Postgraduate Clinical Training Center
Zip code
4313192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
TEL
053-435-2111
m.sano@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu University
Division name
Postgraduate Clinical Training Center
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
TEL
0534352111
Homepage URL
m.sano@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
Tel
0534352111
m.sano@hama-med.ac.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
| 2026 | Year | 06 | Month | 23 | 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 | 02 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study designed to evaluate the accuracy and validity of upper limb volume measurements calculated using circumference measurements and the truncated cone method by comparing them with volumes measured using the water displacement method in patients with upper extremity lymphedema.
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070987
