UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021508 |
|---|---|
| Receipt number | R000024776 |
| Scientific Title | Clinical evaluation of a new navigation system for aortic vascular surgery |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2018/04/04 18:24:50 |
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Basic information
Public title
Clinical evaluation of a new navigation system for aortic vascular surgery
Acronym
Clinical evaluation of a new navigation system for aortic vascular surgery
Scientific Title
Clinical evaluation of a new navigation system for aortic vascular surgery
Scientific Title:Acronym
Clinical evaluation of a new navigation system for aortic vascular surgery
Region
| Japan |
Condition
Condition
Descending thoracic and thoracoabdominal aortic aneurysm
Classification by specialty
| Surgery in general | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of target registration accuracy by using a new registration algorithm
Basic objectives2
Others
Basic objectives -Others
Evaluation of system performance and operation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fiducial localization error (FLE) and target registration error (TRE) in anatomical landmarks
Key secondary outcomes
-Identification of a target intercostal artery
-Length of time required to perform a surgical navigation system
-System error
-Surgeon questionnaire
-Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Supporting a surgeon's decision to identify a target intercostal artery by a navigation system during surgery
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
1)Patients with descending/thoracoabdominal aortic aneurysm
2)Patients indicated for surgery for aortic aneurysm or aortic dissection at Tokyo Women's Medical University
3)Obtaining informed consent for participant
Key exclusion criteria
1)An inadequate case judged by a head of research
2)Emergent operation
3)Patients unfit for aortic surgery
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Yamazaki |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiovascular Surgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
syamazak@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Aomi |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiovascular Surgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
saomi@hij.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Waseda University, National Institute of Health Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京女子医科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 18 | 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
Suspended
Date of protocol fixation
| 2016 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 17 | Day |
Last modified on
| 2018 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024776
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
