A Clinical Study to Visualize Vessels Using Photoacoustic Imaging

JRCT ID: jRCTs032180341

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: vascular disease
• Date of first enrollment: 25/04/2018
• Target sample size: 100
• Study type: Interventional
• Intervention(s): photoacoustic imaging study

Outcome(s)

• Primary Outcome: The capability of the photoacoustic imaging system for visualizing the vascular Lesions of the patients

Secondary Outcome

1. The relationship between the photoacoustic images and the images by other modalities
2. The relationship between the characteristics of the examinees and the photoacoustic images.

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients aged 20 years or older at the time of consent acquisition and suspected to have vascular disease, who are judged by their doctor that in a condition without any problems participating in the research.
2. Healthy persons aged 20 years or older at the time of consent acquisition without mental illness, dementia, who are judged by the doctor in charge that in a condition without any problems participating in the research.
3. Persons in accordance with criteria 1 or 2 who have agreed to participate in this study from their own free will with document consents.

Exclude criteria

1. Pregnancy or possible pregnancy.
2. Who has a skin lesion which a specialist diagnosed not to be irradiated.
3.Prohibited to use together, such as pacemaker, defibrillator, tattoo and so on.
4.The status of immunodeficiency due to neutropenia and so on.
5.Complications that make imaging difficult (e.g. inability to maintain the posture).
6.In cases where it is judged by the research director or the attending physician that it is inappropriate for carrying out this research (e.g. having trouble with the subject's physical condition by keeping the posture during the imaging).

Related Information

• Primary Sponsor: Obara Hideaki
• Source(s) of Monetary Support: Luxonus Pharmaceautical CO,LTD
• Secondary ID(s): Nil known