UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022475 |
|---|---|
| Receipt number | R000025901 |
| Scientific Title | Interface pressures derived from oversize arm sleeves |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2017/04/05 11:58:44 |
* 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
Interface pressures derived from oversize arm sleeves
Acronym
Interface pressures derived from oversize arm sleeves
Scientific Title
Interface pressures derived from oversize arm sleeves
Scientific Title:Acronym
Interface pressures derived from oversize arm sleeves
Region
| Japan |
Condition
Condition
Lymphedema
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the interface pressures obtained by applying oversize arm sleeves
Basic objectives2
Others
Basic objectives -Others
Arm sleves ranging in the size S to LL are applied to S arm, and interface pressures obtained by each arm sleeve are recorded.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interface pressures derived from oversize arm sleeves
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
| Device,equipment |
Interventions/Control_1
Arm sleeve (Medicks Corporation Inc.)
Size S, M, L, LL
3 min per each
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy bolunteer whose right arm is considerd S-size according to brochure prvided by Medics corporation Inc.(Wrist:14.5-16.0cm, Mid forearm:19.0-23.0cm, Mid-upper arm:25.0-30.0cm)
Key exclusion criteria
Those whom we considre inappropiate due to physical and/or mental problem
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimikazu Hamano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2261
kimikazu@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Suehiro |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2261
Homepage URL
ksuehiro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Clinical Science
Yamaguchi University Graduate School of Medicine
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
Address
Tel
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
| 2016 | Year | 05 | Month | 26 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2017 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025901
