UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018893 |
|---|---|
| Receipt number | R000021833 |
| Scientific Title | An exploratory study to developing a diagnostic method using a photoacoustic imaging system. |
| Date of disclosure of the study information | 2015/10/16 |
| Last modified on | 2019/03/13 16:52:06 |
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Basic information
Public title
An exploratory study to developing a diagnostic method using a photoacoustic imaging system.
Acronym
An exploratory study of photoacoustic imaging.
Scientific Title
An exploratory study to developing a diagnostic method using a photoacoustic imaging system.
Scientific Title:Acronym
An exploratory study of photoacoustic imaging.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Breast surgery | Dermatology | Orthopedics |
| Radiology | Plastic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study safety and visualization capabilities of blood vessels in the extremities by using a photoacoustic imaging system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events by using a photoacoustic imaging system.
(Final monitoring is conducted within 90 days after intervention)
Key secondary outcomes
Visualization capabilities of blood vessels in the extremities by using a photoacoustic imaging system.
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, but in the judgment of principle investigator or subinvestigator, additional multi-day examination and multiple examination are conducted on different days. Also multiple scan is conducted in each use of the device, so total number of scans may be estimated to reach into a few dozen times)
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. Healthy volunteers who aged over 20 years and older at the time of informed consent
2. Healthy volunteers who have agreed to participate in this study from their own free will with document consents
Key exclusion criteria
1. People who are pregnancy, suspicion of pregnancy
2. People with cardiac pacemakers
3. People who have any unverified materials (aneurysm clips, nerve stimulators, insulin pumps, intraocular metallic materials) for non-magnetic
4. People who have any following complications in assessment body parts:
Cutaneous erosion, cutaneous ulceration.
Open wounds, excoriations, acnes, surgical wounds.
Infected wounds.
Neurological diseases, vascular diseases.
Any diseases with non-magnetic metal in the body.
Infections.
Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position.
Disorders with deformities of extremities.
5. People who have any following history of disorders:
Mental disorders.
Dementia
Cutaneous erosion, cutaneous ulceration.
Neurological diseases, vascular diseases in assessment body parts:
6. 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
50
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Toi |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Breast Surgery
Zip code
606-8507
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
toi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Matsumoto |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Breast Surgery
Zip code
606-8507
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Homepage URL
yoshiaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Institute
Department
Personal name
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
075-753-4680
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
| 2015 | Year | 10 | Month | 16 | 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
44
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
| 2015 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 16 | 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
| 2015 | Year | 09 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021833
