UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002582 |
|---|---|
| Receipt number | R000003151 |
| Scientific Title | Radial Shock Wave Therapy for secondary lymphedema: A pilot study. |
| Date of disclosure of the study information | 2009/10/05 |
| Last modified on | 2010/10/05 13:44:24 |
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Basic information
Public title
Radial Shock Wave Therapy for secondary lymphedema: A pilot study.
Acronym
Radial Shock Wave Therapy for secondary lymphedema
Scientific Title
Radial Shock Wave Therapy for secondary lymphedema: A pilot study.
Scientific Title:Acronym
Radial Shock Wave Therapy for secondary lymphedema
Region
| Japan |
Condition
Condition
secondary lymphedema
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify safety of radial shock wave therapy in the treatment of secondary lymphedema.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
safety
Key secondary outcomes
extremity volume, quality of life, sepecific symptoms related to lymphedema
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
Radial Shock Wave Therapy
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
1. secondary lymphedema
2. ISL stage II, III
3. Lymphedema of extremities
Key exclusion criteria
1. primary lymphedema
2. lymphedema caused by direct invasion of cancer cells to the lymphatic system
3. venous edema due to thromboembolism
4. generalized edema
5. history of deep venous thrombosis
6. severe heart failure
7. severe respiratory failure
8. acute inflammation (generalized, local)
9. any other causes which can disturb data aquisition (decision should be made by investigators)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Suehiro |
Organization
Yamaguchi University Hospital
Division name
Medical Bioregulation Department of Organ Regulatory Surgery
Zip code
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2260
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Suehiro |
Organization
Yamaguchi University Hospital
Division name
Medical Bioregulation Department of Organ Regulatory Surgery
Zip code
Address
TEL
Homepage URL
ksuehiro-circ@umin.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Hospital
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 10 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 05 | Day |
Last modified on
| 2010 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003151
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
