UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048980 |
|---|---|
| Receipt number | R000055804 |
| Scientific Title | Study of the relationship between abdominal scars and subcutaneous blood vessels using photoacoustic imaging. |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2025/01/24 18:37:33 |
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Basic information
Public title
Study of the relationship between abdominal scars and subcutaneous blood vessels using photoacoustic imaging.
Acronym
Study of the relationship between abdominal scars and subcutaneous blood vessels using photoacoustic imaging.
Scientific Title
Study of the relationship between abdominal scars and subcutaneous blood vessels using photoacoustic imaging.
Scientific Title:Acronym
Study of the relationship between abdominal scars and subcutaneous blood vessels using photoacoustic imaging.
Region
| Japan |
Condition
Condition
A women who have a midline abdominal scar or no scar.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the relationship between the presence or absence of midline abdominal scar and image characteristics and distributions of vessels in the abdomen.
Basic objectives2
Others
Basic objectives -Others
Evaluate the relationship between construction of subcutaneous microvessels around the scar and years since abdominal surgery.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the relationship between the presence or absence of midline abdominal scar and image characteristics and distributions of vessels in the abdomen.
Key secondary outcomes
Evaluate the relationship between construction of subcutaneous microvessels around the scar and years since abdominal surgery.
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To compare the relationship between the presence or absence of midline abdominal scar and image characteristics and distributions of vessels in the abdomen.Using a laser device that is harmless to the human body.It takes about 30 min.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Women who have a midline abdominal scar or no scar. In addition, women who are in good physical condition and judged not to be in need of hospitalization, sufficient to undergo the imaging without pain.
2) Age 18 years or older at the time consent is obtained.
3) Written consent for participation in the research has been obtained from her own free will.
Key exclusion criteria
1)Pregnant or lactating women.
2)With cardiovascular disease.
3)Photosensitizer for photodynamic therapy.
4)A cardiac pacemaker in their body.
5)Severe systemic disease corresponding to ASA-PS (American Society of Anesthesiologists physical status classification) Class 4 or larger.
6)One of the following comorbid illnesses.
Low back pain syndrome that makes it impossible to maintain the patient in the supine position during imaging.
Pain or tenderness at the site of obvious skin ulceration, infection, or scarring at the site of evaluation.
Neurological or orthopedic disease that makes it impossible to hold the standing, sitting, supine, or lateral positions.
Post-artificial joint replacement.
History of abdominal wall scar hernia or ileus.
Conditions with a colostomy.
Patients who have undergone multiple laparotomies.
(except in cases where the attending physician has given permission for the patient to remain in the supine position during imaging.)
Translated with www.DeepL.com/Translator (free version).
7)Difficult in communicating or body positioning during examinations.
8)Research subjects undergoing chemotherapy or radiation therapy for the primary disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Medicine, Kyoto University.
Division name
Departments of Plastic and Reconstructive Surgery.
Zip code
606-8507
Address
Syogoin-Kawaracho, Sakyo-ku
TEL
075-751-3613
prs@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Takaya |
Organization
Graduate School of Medicine, Kyoto University.
Division name
Departments of Plastic and Reconstructive Surgery.
Zip code
606-8507
Address
Syogoin-Kawaracho 54, Sakyo-ku
TEL
075-751-3613
Homepage URL
prs@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Departments of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto University.
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Luxonus Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee.
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院形成外科
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055804
