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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041962
Receipt No. R000047898
Scientific Title An exploratory study to visualization of the skin lesions by using photoacoustic microscope imaging equipment
Date of disclosure of the study information 2020/10/01
Last modified on 2021/03/30

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Basic information
Public title An exploratory study to visualization of the skin lesions by using photoacoustic microscope imaging equipment
Acronym PMIE Study
Scientific Title An exploratory study to visualization of the skin lesions by using photoacoustic microscope imaging equipment
Scientific Title:Acronym PMIE Study
Region
Japan

Condition
Condition Skin lesions with morphological change located in the epidermis and dermis.
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the capability of visualization of the skin lesions in epidermis and dermis by using a photoacoustic microscope imaging equipment.
Basic objectives2 Others
Basic objectives -Others To evaluate the capability of visualization of the skin lesions in epidermis and dermis by using a photoacoustic microscope imaging equipment.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The visualization capability of skin lesions in the epidermis and dermis by using a photoacoustic imaging system.
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 Photoacoustic microscope imaging
(Duration of the device use is for about two minutes.)
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 including pigmented, erythem purpura and vasculitis.

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.People who have skin disorder or complications that make them impossible to try photoacoustic imaging system.

3.People who are judged ineligible to enroll into this clinical study due to limitations in taking examination position by the investigator or the sub-investigators.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Tanikawa
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
Email 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
Email ksujino@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Adventist 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
Email 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
2020 Year 10 Month 01 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 16
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
2020 Year 08 Month 08 Day
Date of IRB
2020 Year 10 Month 01 Day
Anticipated trial start date
2020 Year 10 Month 05 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 10 Month 01 Day
Last modified on
2021 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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