UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046291 |
|---|---|
| Receipt number | R000052826 |
| Scientific Title | An exploratory study to visualization of the skin lesions with vasculitis by using photoacoustic microscope imaging equipment |
| Date of disclosure of the study information | 2021/12/06 |
| Last modified on | 2023/06/08 10:24:18 |
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Basic information
Public title
An exploratory study to visualization of the skin
lesions with vasculitis by using photoacoustic
microscope imaging equipment
Acronym
PMIE Study
Scientific Title
An exploratory study to visualization of the skin
lesions with vasculitis by using photoacoustic
microscope imaging equipment
Scientific Title:Acronym
PMIE Study
Region
| Japan |
Condition
Condition
Skin lesions suspicious for vasculitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We visualize the skin lesions which we suspect vasculitis, purpura, blood blister,ulcer,nodule and so on, by using a photoacoustic microscope imaging equipment.
We compare the visualization and the pathogenesis,then evaluate the equipment performance.
Basic objectives2
Others
Basic objectives -Others
To confirm the relationship between clinical diagnosis (photograph) and photoacoustic image.
To evaluate the performance of photoacoustic microscope imaging system.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To visualize skin lesions of vasculitis by using a photoacoustic imaging system.
To compare the visualization with the pathogenesis.
Key secondary outcomes
To confirm the relationship between clinical diagnosis (photograph) and photoacoustic image.
To evaluate the performance of photoacoustic microscope imaging system.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who visited our hospital with the skin lesions suspected vasculitis and need biopsy for definitive diagnosis.
2. The subjects who have agreed to participate in this study from their own free will with document consents.
Key exclusion criteria
1.Patients who are pregnant or suspected of being pregnant
2.Patients who have complications that make them impossible to try photoacoustic imaging system due to limitations in taking examination position.
3.Patients who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators.
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3823
tanikawa@keio.jp
Public contact
Name of contact person
| 1st name | Kazuyo |
| Middle name | |
| Last name | Sujino |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3823
Homepage URL
ksujino@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Advantest Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2021 | Year | 12 | Month | 06 | 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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052826
