UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010215 |
|---|---|
| Receipt number | R000011967 |
| Scientific Title | A prosepective study of a novel arm sleeve designed for the treatment of secondary upper extremity lymphedema: a pilot study |
| Date of disclosure of the study information | 2013/03/18 |
| Last modified on | 2013/11/25 13:36:16 |
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Basic information
Public title
A prosepective study of a novel arm sleeve designed for the treatment of secondary upper extremity lymphedema: a pilot study
Acronym
Novel arm sleeve study
Scientific Title
A prosepective study of a novel arm sleeve designed for the treatment of secondary upper extremity lymphedema: a pilot study
Scientific Title:Acronym
Novel arm sleeve study
Region
| Japan |
Condition
Condition
Upper extremity lymphedema
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test safety and effectiveness of a novel arm sleeve.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
safety and effectiveness of a novel arm sleeve
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
Apply an existing and a novel arm sleeves.
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
Patients who are under treatment of upper extremity lymphedema using existing arm sleeves.
Key exclusion criteria
1. Systemic edema (hear failure, renal
failure etc.)
2. Lymphedema due to advanced cancer
3. Otherwise, the doctors in charge
decide inappropriate due to the
patients condition.
Target sample size
5
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
TEL
0836-22-2261
Homepage URL
ksuehiro-circ@umin.org
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toko Inc.
Name of secondary funder(s)
Toko Inc.
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
山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 18 | 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
| 2013 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 25 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2013 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011967
