UMIN-CTR Clinical Trial

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

Healthy volunteers

Classification by specialty

Breast surgery	Dermatology	Orthopedics
Radiology	Plastic surgery	Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

toi@kuhp.kyoto-u.ac.jp

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

Email

yoshiaki@kuhp.kyoto-u.ac.jp

Institute

Graduate School of Medicine Kyoto University

Institute

Department

Personal name

Organization

Cabinet Office

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Canon Inc.

Name of secondary funder(s)

Canon Inc.

Organization

Kyoto University Hospital Ethics Committe

Address

Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

16

Day

URL releasing protocol

Publication of results

Published

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

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 related 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