UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054551 |
|---|---|
| Receipt number | R000062331 |
| Scientific Title | Changes in the state of the body before and after a single use of the healing device "CS60": open study |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2024/09/17 10:25:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Changes in the state of the body before and after a single use of the healing device "CS60"
Acronym
CS60 study
Scientific Title
Changes in the state of the body before and after a single use of the healing device "CS60": open study
Scientific Title:Acronym
Changes in the state of the body before and after a single use of the healing device "CS60"
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate changes in physical condition due to use of test article
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Device evaluation
Key secondary outcomes
VAS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform one treatment using test article.
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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects who have pain, stiffness, or other discomfort in the shoulder
Subjects who exercise less than once a week.
3.Subjects who are engaged in desk work
Key exclusion criteria
1. Subjects who exercise regularly or train regularly
2. Subjects with muscle injuries such as fractures or torn muscles, or subjects who feel pain even when lightly tapped or rubbed
3. Subjects currently receiving medical treatment or taking prescription medication
4. Subjects taking medicines that may affect the study (such as knee joint pain or measures for frailty)
5. Subjects who are receiving treatment (hormone replacement therapy, drug therapy, etc.) at a medical institution for the treatment or prevention of disease at the time of obtaining consent, or subjects who are deemed to be in need of treatment
6. Subjects who have participated in other human trials (all human trials using cosmetics, food, medicines, quasi-drugs, medical devices, etc.) within the past 4 weeks, or who plan to participate in other human trials during the planned period of this study
7. Subjects who the principal investigator deems inappropriate
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Japan Innovation Inc.
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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2024 | Year | 06 | Month | 04 | 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
14
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
| 2024 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062331
