UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025169 |
|---|---|
| Receipt number | R000028954 |
| Scientific Title | Investigation of blood flow in patients with vascular diseases using OX ImagerTM. |
| Date of disclosure of the study information | 2016/12/07 |
| Last modified on | 2017/06/28 10:21:49 |
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Basic information
Public title
Investigation of blood flow in patients with vascular diseases using OX ImagerTM.
Acronym
Investigation of blood flow in patients with vascular diseases using OX ImagerTM.
Scientific Title
Investigation of blood flow in patients with vascular diseases using OX ImagerTM.
Scientific Title:Acronym
Investigation of blood flow in patients with vascular diseases using OX ImagerTM.
Region
| Japan |
Condition
Condition
vascular diseases
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate blood flow and to assess peripheral vascular funcion using OX ImagerTM. OX ImagerTM is a new device that uses spatial frequency imaging principles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Optical imaging of extremities by OX ImagerTM is compared between each subject group.
To assess correlation between tissue perfusion measured by optical imaging and clinical symptoms.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Investigation of blood flow using OX ImagerTM before and after treatment.
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 vascular dieseases (including peripheral arterial diseases and chronic venous diseases).
2. Written informed consent.
Key exclusion criteria
1. Patients determined by the investigator to be unsuitable as a subject in this study.
2. less than 20 yeas old.
3. Patients with dementia.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Inoue |
Organization
Tokyo medical and dental university
Division name
vascular surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5255
yoshi.inoue.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Yamamoto |
Organization
Tokyo medical and dental university
Division name
vascular surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5255
Homepage URL
y-yamamoto.srg1@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and dental university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | 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 | 12 | Month | 07 | Day |
Last modified on
| 2017 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028954
