UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060003 |
|---|---|
| Receipt number | R000068626 |
| Scientific Title | Accelerating SaMD Market Implementation: A Validation Study of an Adoption Incentive Model Based on a Two-Stage Economic Evidence Approach |
| Date of disclosure of the study information | 2025/12/07 |
| Last modified on | 2025/12/07 12:45:11 |
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Basic information
Public title
Accelerating SaMD Market Implementation: A Validation Study of an Adoption Incentive Model Based on a Two-Stage Economic Evidence Approach
Acronym
Accelerating SaMD Market Implementation: A Validation Study of an Adoption Incentive Model Based on a Two-Stage Economic Evidence Approach
Scientific Title
Accelerating SaMD Market Implementation: A Validation Study of an Adoption Incentive Model Based on a Two-Stage Economic Evidence Approach
Scientific Title:Acronym
Accelerating SaMD Market Implementation: A Validation Study of an Adoption Incentive Model Based on a Two-Stage Economic Evidence Approach
Region
| Japan |
Condition
Condition
Healthcare Facilities
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the economic value of mediVR KAGURA Basic as a SaMD and to establish an incentive model that will accelerate the implementation of mediVR KAGURA Therapeutic in the market
Basic objectives2
Others
Basic objectives -Others
To demonstrate the economic value of mediVR KAGURA Basic as a SaMD and to establish an incentive model that will accelerate the implementation of mediVR KAGURA Therapeutic in the market
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase 1 Verification
Total therapist time commitment per rehabilitation unit (preparation, implementation, cleanup, and documentation combined)
Phase 2 Verification
Payback period (years) based on ROI simulation
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Questionnaire for Economic Evaluation
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Institutions that have implemented, or are considering the implementation of, the SaMD mediVR KAGURA Basic (official name: mediVR KAGURA Feedback) and/or mediVR KAGURA Therapeutics.
Key exclusion criteria
Institutions that cannot provide consent for participation in this study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
mediVR, Inc.
Division name
Department of Medical Device Development
Zip code
5610872
Address
Ryokuchi Station Building 3F, Terauchi 2-chome 4-1, Toyonaka
TEL
06-6151-4008
hara@medivr.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Hara |
Organization
mediVR, Inc.
Division name
Department of Medical Device Development
Zip code
5610872
Address
Ryokuchi Station Building 3F, Terauchi 2-chome 4-1, Toyonaka
TEL
06-6151-4008
Homepage URL
hara@medivr.jp
Sponsor or person
Institute
mediVR, Inc.
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Committee of the Japan Society of Clinical Research (Nonprofit Incorporated Association)
Address
19-202 Kikuicho, Shinjuku-ku, Tokyo, Japan
Tel
0663186234
sumitani@japanscr.org
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
| 2025 | Year | 12 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 07 | Day |
Last modified on
| 2025 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068626
