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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022767
Receipt No. R000026226
Scientific Title An exploratory study in developing a diagnostic method for skin disease by using the photoacoustic imaging system.
Date of disclosure of the study information 2016/09/13
Last modified on 2019/03/13

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Basic information
Public title An exploratory study in developing a diagnostic method for skin disease by using the photoacoustic imaging system.
Acronym An exploratory study in developing a diagnostic method for skin disease by using the photoacoustic imaging system.
Scientific Title An exploratory study in developing a diagnostic method for skin disease by using the photoacoustic imaging system.
Scientific Title:Acronym An exploratory study in developing a diagnostic method for skin disease by using the photoacoustic imaging system.
Region
Japan

Condition
Condition Suspected cases of vascular lesions
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the imaging capability of the photoacoustic imaging system in skin lesions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Images acquired by the photoacoustic imaging system
Key secondary outcomes Incidence of adverse events by using the photoacoustic imaging system.
(Final monitoring is conducted within 90 days after intervention)

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 Imaging
(Duration of the device use is for one day)
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, and healthy volunteers.
2. Patients who aged over 20 years and older at the time of informed consent.
3. Patients who have agreed to participate in this study from their own free will with document consents.
Key exclusion criteria 1. Pregnant and lactating patients
2. Patients who takes photosensitizer for photodynamic therapy
3. Patients with a cardiac pacemaker
4. Patients who are in poor general status
5. People who have any following complications in assessment body parts:
Open wounds, excoriations, acnes, surgical wounds.
Infected wounds.
Infections.
Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position.
6. People who have any following history of disorders:
Mental disorders.
Dementia.
7. Patients who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators due to limitations in taking examination position and other reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Kabashima
Organization Kyoto University Graduate school of Medicine
Division name Department of Dermatology
Zip code 606-8507
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3310
Email dermamed@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Ishida
Organization Kyoto University Graduate school of Medicine
Division name Department of Dermatology
Zip code 606-8507
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3310
Homepage URL
Email dermamed@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Cabinet Office
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Canon Inc.
Name of secondary funder(s) Canon Inc.

IRB Contact (For public release)
Organization Kyoto University Hospital Ethics Committe
Address Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Tel 0757534680
Email ethcom@kuhp.kyoto-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
2016 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 17
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
2016 Year 06 Month 15 Day
Date of IRB
2016 Year 09 Month 08 Day
Anticipated trial start date
2016 Year 09 Month 08 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 16 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026226

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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