Tokyo, Dec. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060003) titled 'Accelerating SaMD Market Implementation: A Validation Study of an Adoption Incentive Model Based on a Two-Stage Economic Evidence Approach' on Dec. 7.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - mediVR, Inc.
Condition:
Condition - Healthcare Facilities
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Questionnaire for Economic Evaluation
Eligibility:
Age-lower limit - 20
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 Size - 15
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068626
Disclaimer: Curated by HT Syndication.
