UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028180 |
|---|---|
| Receipt number | 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 15:27:29 |
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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
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
wakayama.koji@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
