臨床研究等提出・公開システム

Date of registration	Mar. 03, 2023
Last modified on	Mar. 03, 2023
Trial ID	jRCT1030220679

Scientific Title	Medical application of photoacoustic imaging: Investigation of the utility of peripheral vascular imaging in patients with peripheral arterial occlusive disease
Public Title	Medical application of photoacoustic imaging

Contact for Scientific Queries	Name	Yokoyama Naoyuki
	Affiliation	Teikyo University Hospital
	Address	2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
	Telephone	+81-3-3964-1211
	E-mail	33nao@med.teikyo-u.ac.jp
Contact for Public Queries	Name	Yokoyama Naoyuki
	Affiliation	Teikyo University Hospital
	Address	2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
	Telephone	+81-3-3964-1211
	E-mail	33nao@med.teikyo-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 03, 2023
Actual date of first enrollment		Feb. 28, 2023
Target sample size		20
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients scheduled for treatment of lower extremity artery diseas at this hospital are included. Treatment may include medical therapy, invasive revascularization, or lower extremity amputation. Patients should have a lower extremity arteriography to identify the anatomy of the occluded vessel.
	Exclusion Criteria	Exclusion criteria: Patients who fulfill any of the following conditions are excluded. 1) Patients under 20 years of age. 2) Patients whose lesions are difficult to evaluate by photoacoustic imaging due to artifacts. 3) Patients who are unable to receive informed consent.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Peripheral Artery Disease
Primary Outcome(s)		To determine the safety of using photoacoustic imaging to assess lower extremity blood flow in patients with peripheral artery disease. Also, whether it is possible to evaluate lower extremity blood flow. Furthermore, we will examine whether it is possible to evaluate changes before and after treatment.

Primary Sponsor	NaoyukiYokoyama

Source of Monetary Support	Teikyo University Advanced Comprehensive Research Organization
Secondary Sponsor	Not applicable

Name of Certified Review Board	Teikyo University School o Research Review Committee
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
Telephone	+81-3-3964-7757
E-Mail	tkumrb-office@teikyo-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 26, 2019

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none