Unique ID issued by UMIN | UMIN000028001 |
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Receipt number | R000032067 |
Scientific Title | An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels |
Date of disclosure of the study information | 2017/09/14 |
Last modified on | 2019/03/13 17:05:25 |
An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
An intervention study for preoperative mapping of cutaneous and subcutaneous perforator vessels
Japan |
Patients who are scheduled for anterolateral thigh free flap surgery
Plastic surgery |
Others
NO
To assess the cutaneous and subcutaneous blood vessel network using photoacoustic imaging
Safety,Efficacy
Exploratory
Imaging capability of the photoacoustic imaging system for blood vessels in the extremities
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
(Duration of the device use is for one day)
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients who are scheduled for anterolateral thigh free flap surgery
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 with greater than or equal to class 4 (Patients with severe systemic disease that is a constant threat to life)
in ASA-PS (American Society of Anaesthesiologists physical status classification)
5. People who have any following complications
Infections of the evaluation region
Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position
6. 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.
10
1st name | Susumu |
Middle name | |
Last name | Saito |
Graduate School of Medicine Kyoto University
Plastic and Reconstructive Surgery
606-8507
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
075-751-3613
prs@kuhp.kyoto-u.ac.jp
1st name | Itaru |
Middle name | |
Last name | Tsuge |
Graduate School of Medicine Kyoto University
Plastic and Reconstructive Surgery
606-8507
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
075-751-3613
prs@kuhp.kyoto-u.ac.jp
Graduate School of Medicine Kyoto University
Cabinet Office (Japan)
Japanese Governmental office
Japan
Canon Inc.
Hitachi, Ltd.
Canon Inc.
Hitachi, Ltd.
Kyoto University Hospital Ethics Committe
Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
0757534680
ethcom@kuhp.kyoto-u.ac.jp
NO
2017 | Year | 09 | Month | 14 | Day |
Published
9
Completed
2017 | Year | 06 | Month | 14 | Day |
2017 | Year | 09 | Month | 11 | Day |
2017 | Year | 09 | Month | 11 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 06 | Month | 29 | Day |
2019 | Year | 03 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032067
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