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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029786
Receipt No. R000032045
Scientific Title An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/11

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

Condition
Condition Patients with peripheral circulatory disturbance
Healthy volunteers
Classification by specialty
Surgery in general Vascular surgery 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 Visualization capabilities of blood vessels in the extremities by using a photoacoustic imaging system.
Key secondary outcomes Comparison between photo acoustic images and images of other modality

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 or patients with peripheral circulatory disorders who aged over 20 years and older at the time of informed consent

2. The subjects 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 who have skin disorder that is not suitable for this trial judging by specialist.
3. People with cardiac pacemakers, defibrillator, and /or tattoo.
4. People with immunodeficiency such as leukopenia.
5. People who have complications that make them impossible to try photoacoustic imaging system.
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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Obara
Organization Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3802
Email obara@z3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Obara
Organization Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3802
Homepage URL
Email obara@z3.keio.jp

Sponsor
Institute Keio University School of medicine
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 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
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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 01 Day
Last modified on
2017 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032045

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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