UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of blood flow in patients with vascular diseases using OX ImagerTM.
Title of the study (Brief title)	Investigation of blood flow in patients with vascular diseases using OX ImagerTM.
Region	Japan

Condition
Condition	vascular diseases
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate blood flow and to assess peripheral vascular funcion using OX ImagerTM. OX ImagerTM is a new device that uses spatial frequency imaging principles.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Optical imaging of extremities by OX ImagerTM is compared between each subject group. To assess correlation between tissue perfusion measured by optical imaging and clinical symptoms.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Investigation of blood flow using OX ImagerTM before and after treatment.
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with vascular dieseases (including peripheral arterial diseases and chronic venous diseases). 2. Written informed consent.
Key exclusion criteria	1. Patients determined by the investigator to be unsuitable as a subject in this study. 2. less than 20 yeas old. 3. Patients with dementia.
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshinori Inoue
Organization	Tokyo medical and dental university
Division name	vascular surgery
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5255
Email	yoshi.inoue.srg1@tmd.ac.jp

Public contact
Name of contact person	Yohei Yamamoto
Organization	Tokyo medical and dental university
Division name	vascular surgery
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5255
Homepage URL
Email	y-yamamoto.srg1@tmd.ac.jp

Sponsor
Institute	Tokyo medical and dental university
Institute
Department

Funding Source
Organization	Tokyo medical and dental university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 07 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 28 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 07 Day
Last modified on	2017 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028954