UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059378 |
|---|---|
| Receipt number | R000067889 |
| Scientific Title | Photoacoustic Imaging for Postoperative Assessment of Circulation after Digital Replantation and Digital Artery Reconstruction: An Exploratory Clinical Study |
| Date of disclosure of the study information | 2025/10/13 |
| Last modified on | 2025/10/15 05:59:31 |
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Basic information
Public title
A Study on a New Test to See Blood Flow Using Light
Acronym
PA-Hand Study
Scientific Title
Photoacoustic Imaging for Postoperative Assessment of Circulation after Digital Replantation and Digital Artery Reconstruction: An Exploratory Clinical Study
Scientific Title:Acronym
PAI test for reconstructed vessels
Region
| Japan |
Condition
Condition
patients who have undergone finger replantation or digital artery reconstruction
Classification by specialty
| Orthopedics | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to use photoacoustic imaging (PAI) to provide detailed three-dimensional visualization of the morphology and hemodynamics of anastomosed vessels in fingers that have survived after digital replantation. Specifically, the study aims to (i) evaluate the extent of arterial reconstruction following replantation and (ii) assess whether safe and effective vascular pathways can be identified preoperatively for planning secondary procedures. Conventional clinical assessment methods have been insufficient to fully delineate the course and patency of microvasculature, leaving surgeons reliant on empirical judgment; this study seeks to provide novel insights into long-term hemodynamics of replanted digits through three-dimensional imaging.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Three-dimensional morphological assessment of digital vessels after replantation or arterial reconstruction using photoacoustic imaging (PAI)
2.Evaluation of vascular patency and blood flow using PAI, including estimation of oxygenation via S-factor analysis
3.Visibility and reproducibility of vascular imaging in digits followed for more than six months postoperatively
4.Feasibility and image quality of PAI acquisition under different hand positioning and stabilization methods (e.g., water immersion, water bag, or gel)
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 undergone reconstructive surgery for limb or hand trauma, or healthy volunteers who have completed such treatment and are deemed by the principal investigator or subinvestigator to be in a suitable health condition for study participation.
2. Individuals aged 18 years or older at the time of obtaining consent.
3. Individuals who have provided written informed consent voluntarily.
Key exclusion criteria
1.Individuals who are pregnant or may possibly be pregnant.
2.Individuals who are taking photosensitizing agents used for photodynamic therapy (e.g., Photofrin).
3.Individuals deemed by the principal investigator or subinvestigator to be unsuitable for participation in this study, such as those whose health condition may be adversely affected by the imaging position or posture required for the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Katsuyasu |
| Middle name | |
| Last name | Fukasawa |
Organization
Kanto rosai hospital
Division name
Orthopedics
Zip code
2110021
Address
1-1 Kishizumi-cho, Muko-cho, Nakahara-ku, Kawasaki City
TEL
0444113131
fkatsu@hotmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kamekura |
Organization
Kanto rosai hospital
Division name
the Dept. of Orthopedics
Zip code
2110021
Address
1-1 Kishizumi-cho, Muko-cho, Nakahara-ku, Kawasaki City
TEL
0444113131
Homepage URL
fkatsu@hotmail.com
Sponsor or person
Institute
Kanto rosai hospital
Institute
Department
Personal name
Funding Source
Organization
no organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Luxonus Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanto rosai hospital Ethics Committe
Address
1-1 kizukisumiyoshi-cho, nakahara-ku, Kawasaki City
Tel
0444113131
fkatsu@hotmail.com
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
| 2025 | Year | 10 | Month | 13 | 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
4
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2030 | Year | 08 | 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
| 2025 | Year | 10 | Month | 12 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067889
