Unique ID issued by UMIN | UMIN000022896 |
---|---|
Receipt number | R000026342 |
Scientific Title | An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system |
Date of disclosure of the study information | 2019/09/13 |
Last modified on | 2019/03/13 17:01:11 |
An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system
An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system
An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system
An exploratory study in developing a diagnostic method for rheumatic diseases using a photoacoustic imaging system
Japan |
Rheumatic diseases (rheumatoid arthritis, polymyalgia rheumatica, palindromic rheumatism, RS3PE syndrome, Sjogren's syndrome, psoriatic arthritis, seronegative spondyloarthropathy, systemic connective tissue disease).
Orthopedics |
Others
NO
To assess the imaging capability of synovitis (blood flow in the synovial hypertrophy) in joints, synovial bursa or tendon sheath using a photoacoustic imaging system for undifferentiated arthritis and rheumatic diseases.
Safety,Efficacy
Contrast and volume of photoacoustic images corresponding to synovitis (blood flow in the synovial hyperplasia) in joints, synovial bursa or tendon sheath for undifferentiated arthritis and rheumatic diseases.
Incidence of adverse events by using the photoacoustic imaging system.
(Final monitoring is conducted within 90 days after intervention)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
Photoacoustic Imaging
(Use of the device is for up to three days)
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with undifferentiated arthritis and rheumatic disease (rheumatoid arthritis, polymyalgia rheumatica, palindromic rheumatism, RS3PE syndrome, Sjogren's syndrome, psoriatic arthritis, seronegative spondyloarthropathy, systemic connective tissue disease) those who were enrolled in KURAMA cohort study.
2. Patients who aged over 20 years and older at the time of informed consent.
3. Patients who have agreed to participate in this study from their own free will with document consents.
1. Pregnant and lactating patients
2. Patients who takes photosensitizer for photodynamic therapy
3. Patients with a cardiac pacemaker
4. Patients who are in poor general status
5. People who have any following complications in assessment body parts:
Open wounds, excoriations, acnes, surgical wounds.
Infected wounds.
Infections.
Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position.
6. People who have any following history of disorders:
Mental disorders.
Dementia.
7. Patients who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators due to communication difficulty, limitations in taking examination position and other reasons.
40
1st name | Shuichi |
Middle name | |
Last name | Matsuda |
Graduate School of Medicine Kyoto University
Department of Orthopaedic Surgery
606-8507
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
075-751-3366
seikei@kuhp.kyoto-u.ac.jp
1st name | Kouichi |
Middle name | |
Last name | Murata |
Graduate School of Medicine Kyoto University
Department of the Control for Rheumatic Diseases
606-8507
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
075-751-3366
morifuru@kuhp.kyoto-u.ac.jp
Kyoto University
Cabinet Office
Japanese Governmental office
Japan
Canon Inc.
Canon Inc.
Kyoto University Hospital Ethics Committe
Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
0757534680
ethcom@kuhp.kyoto-u.ac.jp
NO
2019 | Year | 09 | Month | 13 | Day |
Published
14
Completed
2016 | Year | 06 | Month | 15 | Day |
2016 | Year | 09 | Month | 08 | Day |
2016 | Year | 09 | Month | 08 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 06 | Month | 27 | Day |
2019 | Year | 03 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026342