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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028180
Receipt No. R000032204
Scientific Title Evaluation of adsorption type blood purifier Lixelle by upper limb disorder evaluation table DASH
Date of disclosure of the study information 2017/07/14
Last modified on 2018/02/28

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Basic information
Public title Evaluation of adsorption type blood purifier Lixelle by upper limb disorder evaluation table DASH
Acronym Effect of Lixelle on upper limb disorders
Scientific Title Evaluation of adsorption type blood purifier Lixelle by upper limb disorder evaluation table DASH
Scientific Title:Acronym Effect of Lixelle on upper limb disorders
Region
Japan

Condition
Condition Dialisis Related Amyloidosis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Consider whether relaxation of obstacles in upper limbs is caused by therapeutic intervention by recital
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Change in DASH score
Key secondary outcomes Change in grip strength
Change in pain
Change in TUAGT
Change in range of motion of joint
Changes in blood collection data

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Continuing treatment for one year by recital
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Lixelle insurance patient
Key exclusion criteria Patients who underwent open carpal tunnel within 3 months.
Patients who can not answer the DASH questionnaire.
Patients judged inappropriate by the research director
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuchiya_Ken
Organization Tokyo Women's Medical University
Division name Department of Blood Purification
Zip code
Address 8-1, Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL 03-3353-8111
Email tsuchiya@kc.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wakayama_Koji
Organization Tokyo Women's Medical University
Division name Department of clinical engineering
Zip code
Address 8-1, Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL 03-3353-8111
Homepage URL
Email wakayama.koji@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Kaneka Corporation
Organization
Division
Category of Funding Organization Profit 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 東京女子医科大学病院、須田クリニック、須田内科クリニック、下落合クリニック、阿佐ヶ谷すずき診療所、南池袋診療所、高円寺すずきクリニック

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 14 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 11 Day
Last modified on
2018 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032204

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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