UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049545 |
|---|---|
| Receipt number | R000056397 |
| Scientific Title | Three-dimensional analysis of limb arteriovenous malformations using photoacoustic imaging |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/08/31 19:49:32 |
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Basic information
Public title
Three-dimensional analysis of limb arteriovenous malformations using photoacoustic imaging
Acronym
Three-dimensional analysis of limb arteriovenous malformations using photoacoustic imaging
Scientific Title
Three-dimensional analysis of limb arteriovenous malformations using photoacoustic imaging
Scientific Title:Acronym
Three-dimensional analysis of limb arteriovenous malformations using photoacoustic imaging
Region
| Japan |
Condition
Condition
arteriovenous and venous malformations
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize photoacoustic three-dimensional visualization of limb arteriovenous malformations.
Basic objectives2
Others
Basic objectives -Others
To compare differences of photoacoustic visualization between arteriovenous malformation and venous malformation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of cases in which the localization of nidus in arteriovenous malformations could be identified by photoacoustic imaging, and frequency of cases in which localization of abnormal vessels in venous malformations could be identified by photoacoustic imaging.
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
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
Photoacoustic imaging examination
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
Male and Female
Key inclusion criteria
1. Patients who have been diagnosed with arteriovenous or venous malformations of the limbs
2. Patients who aged over 18 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
Key exclusion criteria
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.
Target sample size
10
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
Plastic and Reconstructive Surgery
Zip code
606-8507
Address
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL
075-751-3613
prs@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamanaka |
Organization
Graduate School of Medicine Kyoto University
Division name
Plastic and Reconstructive Surgery
Zip code
606-8507
Address
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL
075-751-3613
Homepage URL
prs@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
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 Hospital Ethics Committe
Address
Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Tel
0757534680
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | 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 | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056397
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
