UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047188 |
|---|---|
| Receipt number | R000053818 |
| Scientific Title | Ocular blood flow by laser speckle flowgraphy to predict postoperative hyper perfusion after CEA |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/03/17 09:38:08 |
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Basic information
Public title
Ocular blood flow by laser speckle flowgraphy to predict postoperative hyper perfusion after CEA
Acronym
Ocular blood flow by laser speckle flowgraphy to predict postoperative hyper perfusion after CEA
Scientific Title
Ocular blood flow by laser speckle flowgraphy to predict postoperative hyper perfusion after CEA
Scientific Title:Acronym
Ocular blood flow by laser speckle flowgraphy to predict postoperative hyper perfusion after CEA
Region
| Japan |
Condition
Condition
carotid artery stenosis
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the efficacy of LSFG to predict postoperative hyperperfusion after carotid endarterectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
monitoring of LSFG and ocular blood flow
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Use of mydriatic drugs during opreration
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 undergoing CEA for carotid artery stenosis for stroke prevention
Key exclusion criteria
glaucoma patient
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kotsugi |
Organization
Nara Medical University
Division name
Neurosurgery
Zip code
6348521
Address
Shijo-cho 840, Kashihara-city, Nara
TEL
0744223051
igustok@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Kotsugi |
Organization
Nara Medical University
Division name
Neurosurgery
Zip code
6348521
Address
Shijo-cho 840, Kashihara-city, Nara
TEL
0744223051
Homepage URL
igustok@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Nara Medical University
Address
Shijo-cho 840, Kashihara-city, Nara
Tel
0744223051
igustok@naramed-u.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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
no URL
Publication of results
Unpublished
Result
URL related to results and publications
no URL
Number of participants that the trial has enrolled
9
Results
Difficult to analyze due to lack of cases
Results date posted
| 2024 | Year | 03 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who have undergone CEA
Participant flow
no date
Adverse events
none
Outcome measures
no date
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 16 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 16 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053818
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
