A Clinical Study to Visualize Vessels Using Photoacoustic Imaging

JRCT ID: jRCTs032210555

Registered date:18/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Varix, peripheral vascular disease, diabetes mellitus, vasculitis, Raynaud s syndrome, hemangioma, v
• Date of first enrollment: 21/04/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): hotoacoustic imaging study

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: The capability of the photoacoustic imaging system for visualizing the vascular lesion of the patients (The blood vessel, inner diameter, and three-dimensional running directions of the blood vessels are evaluated in three phases of evaluations which are inability to depict, incomplete depiction, and good depiction.)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1.Patients aged 12 years to 85 years 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.Persons in accordance with criteria 1 who have agreed to participate in this study from their own free will with document consents.

Exclude criteria

1. Pregnancy or possible pregnancy.
2.The status of immunodeficiency due to neutropenia and so on.
3.Complications that make imaging difficult (e.g. inability to maintain the posture).
4.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
• Secondary Sponsor: Imanishi Nobuaki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development