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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||
Condition | Skin lesions with morphological change located in the epidermis and dermis. | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Photoacoustic microscope imaging
(Duration of the device use is for about two minutes.) |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 16 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |