UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035062 |
|---|---|
| Receipt number | R000039972 |
| Scientific Title | Prospective Study of Usefulness of 3-Dimensional Printer Model for Appropriate Microcatheter Shaping during Unruptured Intracranial Aneurysm Coiling |
| Date of disclosure of the study information | 2019/01/10 |
| Last modified on | 2023/08/10 09:35:42 |
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Basic information
Public title
Prospective Study of Usefulness of 3-Dimensional Printer Model for Appropriate Microcatheter Shaping during Unruptured Intracranial Aneurysm Coiling
Acronym
Unruptured Intracranial Aneurysm 3-Dimensional Printer Model Study
Scientific Title
Prospective Study of Usefulness of 3-Dimensional Printer Model for Appropriate Microcatheter Shaping during Unruptured Intracranial Aneurysm Coiling
Scientific Title:Acronym
Unruptured Intracranial Aneurysm 3-Dimensional Printer Model Study
Region
| Japan |
Condition
Condition
Unruptured Intracranial Aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of cerebral aneurysm 3D-printer model for the appropriate microcatheter shaping
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the microcatheter shaping between 2D image and cerebral aneurysm 3D model
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
First, the microcatheter shaped with 2D-images is insert into the aneurysm. Then, the micro catheter shaped with cerebral aneurysm 3D printer model is insert into the aneurysm. Physicians asses which microcatheter shape was appropriated for the procedure.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unruptured intracranial aneurysm treated with endovascular coiling at Juntendo University Hospital
Key exclusion criteria
Patients determinated to be unsuitable as asubject by researchers.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Oishi |
Organization
Juntendo University
Division name
Department of Neuroendovascular Therapy
Zip code
113-8421
Address
2-1-1, Bunkyo-ku, Hongo, Tokyo, Japan
TEL
+81-3-3813-3150
ohishi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Oishi |
Organization
Juntendo University
Division name
Department of Neuroendovascular Therapy
Zip code
113-8421
Address
2-1-1, Bunkyo-ku, Hongo, Tokyo, Japan
TEL
+81-3-3813-3150
Homepage URL
ohishi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.ac.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 | 01 | Month | 10 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
10
Results
Not signifiant difference
Results date posted
| 2021 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cases underwent coiling
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039972
