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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034051
Receipt No. R000031138
Scientific Title A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Date of disclosure of the study information 2018/09/06
Last modified on 2019/03/28

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Basic information
Public title
A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Acronym
A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Scientific Title
A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Scientific Title:Acronym
A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Region
Japan

Condition
Condition peripheral arterial disease
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Conventionally, the non-invasive blood flow evaluation method of limb arterial disease such as obstructive arteriosclerosis or Buerger disease is used as a gold standard for ankle-ankle artery pressure ratio (ABI), and in recent years it has been reported that skin perfusion pressure (SPP) and percutaneous oxygen partial pressure (TcPO 2) have also been clinically applied. However, these tests were time consuming and painful in some cases. OX Imager (manufactured by modulated Imaging, USA) can measure oxygen metabolism information of oxygen saturation, oxygenated hemoglobin concentration, deoxygenated hemoglobin concentration inside living tissue quantitatively and as an image without contacting the living body It is a possible device.
We will evaluate the blood flow of the ischemic limb using this device and consider the correlation with the conventional method ABI and the comparison with the conventional method with TcPO 2 and SPP.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes q
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 Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Shoot foot with OX Imager. Record the values of blood oxygen saturation (StO 2), oxyhemoglobin (HbO 2), deoxyhemoglobin (HbR) of tissues obtained by photographing. The inspection time is about 30 seconds. The patient has no adverse effect at all.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Persons who aged 20 or over and under 80 are aged acquisition days.
Person who consented to participate in this research in document
Healthy volunteers
Patients with peripheral artery disease
Key exclusion criteria Persons who may have pregnancy and pregnancy
Person who the researcher judged inappropriate
People who can not obtain consent to participate in this research
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Unno
Organization Hamamatsu University School of Medicne
Division name Second Deparment of Surgery
Zip code 431-3192
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka prefecture,Japan
TEL 0534352111
Email d16007@hama-med.ac.jp

Public contact
Name of contact person
1st name Takafumi
Middle name
Last name Kayama
Organization Hamamatsu University School of Medicne
Division name Second Deparment of Surgery
Zip code 431-3192
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka prefecture,Japan
TEL 0534352111
Homepage URL
Email d16007@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicne

Second Deparment of Surgery
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicne

Second Deparment of Surgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Clinical Research Review Board of Hamamatsu University School of Medicine
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka prefecture,Japan
Tel 0534352111
Email kenkyou.s@hama-med.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 17-006
Org. issuing International ID_1 Hamamatsu University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 浜松医科大学 第二外科

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 04 Month 04 Day
Anticipated trial start date
2017 Year 04 Month 04 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 06 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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