UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036508 |
|---|---|
| Receipt number | R000041520 |
| Scientific Title | Cost-effectiveness analysis of endovascular therapy for unruptured brain aneurysms: Health economics evaluation and clinical outcomes as a result of using innovative medical devices |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/10/13 23:26:09 |
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Basic information
Public title
Cost-effectiveness analysis of endovascular therapy for unruptured brain aneurysms: Health economics evaluation and clinical outcomes as a result of using innovative medical devices
Acronym
Cost-effectiveness analysis of endovascular therapy for unruptured brain aneurysms: Health economics evaluation and clinical outcomes as a result of using innovative medical devices
Scientific Title
Cost-effectiveness analysis of endovascular therapy for unruptured brain aneurysms: Health economics evaluation and clinical outcomes as a result of using innovative medical devices
Scientific Title:Acronym
Cost-effectiveness analysis of endovascular therapy for unruptured brain aneurysms: Health economics evaluation and clinical outcomes as a result of using innovative medical devices
Region
| Japan |
Condition
Condition
Unruptured brain aneurysms
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cost-effectiveness and clinical outcomes of endovascular therapy for unruptured brain aneurysms
Basic objectives2
Others
Basic objectives -Others
cost-effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3 months total healthcare expenditures including initial endovascular therapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subject with unruptured aneurysm who underwent endovascular therapy using the flow diverter stent in accordance with the guideline published by the Japan Neurosurgical Society and site indication as a standard of care
Key exclusion criteria
Subject with ruptured aneurysm
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Wataro |
| Middle name | |
| Last name | Tsuruta |
Organization
Toranomon Hospital
Division name
Department of Endovascular Neurosurgery
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
wataro@cf6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Wataro |
| Middle name | |
| Last name | Tsuruta |
Organization
Toranomon Hospital
Division name
Department of Endovascular Neurosurgery
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
wataro@cf6.so-net.ne.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital IRB
Address
2-2-2 Toranomon, Minato-ku, Tokyo
Tel
03-3588-1111
chiken-jim2@toranomon.gr.jp
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
| 2019 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
75
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
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cost-effectiveness analysis using medical records and healthcare claims
Management information
Registered date
| 2019 | Year | 04 | Month | 14 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041520
