UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034051 |
|---|---|
| Receipt number | 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 10:37:27 |
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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
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
d16007@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicne
Second Deparment of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031138
