Unique ID issued by UMIN | UMIN000029786 |
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Receipt number | R000032045 |
Scientific Title | An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system. |
Date of disclosure of the study information | 2017/12/01 |
Last modified on | 2021/11/04 12:01:27 |
An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.
An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.
An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.
An exploratory study to developing a diagnostic method for vascular disease using a photoacoustic imaging system.
Japan |
Patients with peripheral circulatory disturbance
Healthy volunteers
Surgery in general | Vascular surgery | Radiology |
Plastic surgery | Adult |
Others
NO
To study safety and visualization capabilities of blood vessels in the extremities by using a photoacoustic imaging system.
Safety,Efficacy
Exploratory
Visualization capabilities of blood vessels in the extremities by using a photoacoustic imaging system.
Comparison between photo acoustic images and images of other modality
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
Photoacoustic Imaging
(Duration of the device use is for one day, but in the judgment of principle investigator or subinvestigator, additional multi-day examination and multiple examination are conducted on different days. Also multiple scan is conducted in each use of the device, so total number of scans may be estimated to reach into a few dozen times)
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy volunteers or patients with peripheral circulatory disorders who aged over 20 years and older at the time of informed consent
2. The subjects who have agreed to participate in this study from their own free will with document consents
1. People who are pregnancy, suspicion of pregnancy.
2. People who have skin disorder that is not suitable for this trial judging by specialist.
3. People with cardiac pacemakers, defibrillator, and /or tattoo.
4. People with immunodeficiency such as leukopenia.
5. People who have complications that make them impossible to try photoacoustic imaging system.
6. People who are judged ineligible to enroll into this clinical study due to limitations in taking examination position by the investigator or the sub-investigators.
100
1st name | Hideaki |
Middle name | |
Last name | Obara |
Keio University
Department of Surgery
160-8582
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
03-5363-3802
obara@z3.keio.jp
1st name | Hideaki |
Middle name | |
Last name | Obara |
Keio University
Department of Surgery
160-8582
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
03-5363-3802
obara@z3.keio.jp
Keio University School of medicine
Cabinet Office
Japanese Governmental office
Japan
Certified Review Board of Keio
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
NO
2017 | Year | 12 | Month | 01 | Day |
Unpublished
23
The primary endpoint (drawing ability) was accomplished by all 23 patients.
The secondary endpoint (relationship with existing inspections) is being analyzed.
2021 | Year | 11 | Month | 04 | Day |
Sex Age (years) Healthy or Patient
M 85 Patient
F 73 Patient
F 81 Patient
F 80 Patient
F 81 Patient
M 25 Patient
M 62 Patient
F 51 Patient
F 66 Healthy
F 53 Patient
F 23 Healthy
M 69 Patient
M 72 Patient
F 77 Patient
M 78 Patient
M 71 Patient
F 80 Patient
F 81 Patient
F 81 Patient
F 78 Patient
F 50 Healthy
F 48 Patient
F 50 Healthy
Occurrence of diseases related to the clinical study and its progress
Implementation date: April 25, 2018
A patient who was suspected to have lymphedema and a micro-arteriovenous shunt was hospitalized on April 25, 2018 for angiography and embolization by plastic surgery. Photoacoustic imaging (PAI) was started around 12:00 on the same day, but the PAI operator was unaware of the presence of cellulitis. (The patient s body temperature at hospitalization was 36.5 degrees Celsius, and he did not complain of any problems from the beginning to end of the imaging procedure. Although swelling and redness of the affected limb were observed, the patient reported that it was the same as usual.)
After the PAI, the patient returned to the ward on his own and prepared for the angiography procedure (securement of a peripheral venous route, insertion of an indwelling bladder catheter, and intramuscular injection of a sedative), which was the main purpose of hospitalization. During this time, the presence of cellulitis was unnoticed by other medical personnel.
The patient was transferred to the angiography suite for examination at around 16:00, and his body temperature was found to be 40 degrees Celsius with cellulitis extending from the affected limb to the abdomen.
The patient s family later reported that he had had a fever and pain in the affected limb for a few days, but the medical staff had not been informed because the patient did not have a fever on the day of hospitalization. The next day (April 26), he was examined by a dermatologist, and medication for herpes zoster was started because herpes infection could not be ruled out as the cause of the abdominal rash.
The patient was diagnosed with cellulitis caused by lymphedema of the lower extremities. The angiography procedure was postponed, and treatment of cellulitis by administration of antibiotics was started. Blood testing showed that his white blood cell count was 8200/uL and C-reactive protein concentration was 23.76 mg/L immediately after SAE (April 25), and these values decreased to 6200/uL and 19.98 mg/L the next morning (April 26), respectively.
*After a dermatological examination on April 26, treatment of herpes zoster with antiviral drugs was started.
*No fever was observed on April 28, and the abdominal rash was improved.
*Blood testing on April 29 showed a white blood cell count of 8500/uL and C-reactive protein concentration of 13.99 mg/L.
*Blood culture results on April 25 and May 1 were negative.
*After a dermatological examination on May 2, the patient was discharged on May 3.
Evaluation of safety and scientific validity of clinical study
Based on the patient s medical history, it seemed that the symptoms of cellulitis had appeared before hospitalization. Because the fever had diurnal variation in the early stage after its onset, the fever had relieved and the patient s symptoms had improved at the time of PAI. Therefore, PAI was performed without the medical staff having noticed the presence of cellulitis, and the symptoms recurred thereafter. In this case, instead of PAI having caused the disease, we considered that the patient originally had the disease before hospitalization; thus, the effect of PAI is limited. In addition, all patients medical histories, general conditions, and lower limb symptoms were more thoroughly examined after this incident. No SAE was observed in the other patients.
Based on the above, we determined that there is no problem with the safety and scientific validity of this study.
Completed
2017 | Year | 09 | Month | 08 | Day |
2017 | Year | 12 | Month | 20 | Day |
2017 | Year | 11 | Month | 13 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2022 | Year | 12 | Month | 20 | Day |
2017 | Year | 11 | Month | 01 | Day |
2021 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032045
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