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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002582
Receipt No. 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

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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
Email

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
Email ksuehiro-circ@umin.ac.jp

Sponsor
Institute Yamaguchi University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003151

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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