Evaluation of usefulness of blood flow measurement device

JRCT ID: jRCTs032200072

Registered date:01/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: arteriosclerosis obliterans (ASO) or suspection of the ASO
• Date of first enrollment: 01/08/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Blood flow measurement by prototype device

Outcome(s)

• Primary Outcome: Comparative evaluation of blood flow in non-invasive blood flow test device and ultrasonic doppler blood flow test

Secondary Outcome

1. Comparison between ABI (ankle-brachial pressure index) and lower limb blood flow by non-invasive blood flow test device
2. Comparison between imaging by CT or MRI and lower limb blood flow by non-invasive blood flow test device

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1. Patients with atherosclerosis obliterans (ASO) or suspection of the ASO.
2. Patients are more than 20 years old and less than 90 years old.
3. Patients are given sufficient written explanations of the study and written informed consent.

Exclude criteria

1. Patients cannot measure blood flow by the ultrasonography.
2. Patients are Performance Status 4.
3. Patients had implantable devices such as pacemakers.
4. Patients had scars or inflammation on the attachemnet site of the electrodes.
5. Patients are pregnants or doubt of the pregnancy.
6. Patients are considered inappropriate participants in this study by the investigators.

Related Information

• Primary Sponsor: Horinaka Shigeo
• Source(s) of Monetary Support: Fukuda Denshi Co., LTD