UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060913 |
|---|---|
| Receipt number | R000069712 |
| Scientific Title | Usefulness of indocyanine green fluorescence imaging for evaluating testicular blood flow in pediatric testicular torsion |
| Date of disclosure of the study information | 2026/03/15 |
| Last modified on | 2026/03/12 17:03:12 |
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Basic information
Public title
Usefulness of indocyanine green fluorescence imaging for evaluating testicular blood flow in pediatric testicular torsion
Acronym
ICG perfusion assessment study for pediatric testicular torsion
Scientific Title
Usefulness of indocyanine green fluorescence imaging for evaluating testicular blood flow in pediatric testicular torsion
Scientific Title:Acronym
ICG perfusion assessment study for pediatric testicular torsion
Region
| Japan |
Condition
Condition
testicular torsion
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the usefulness of objectively assessing testicular blood flow using indocyanine green ICG fluorescence imaging during emergency surgery for pediatric testicular torsion. Traditionally the decision to preserve or remove the testis has depended on the surgeons macroscopic findings and clinical experience. By introducing ICG based blood flow assessment this study seeks to determine whether the degree of testicular ischemia can be evaluated more objectively and whether more appropriate intraoperative treatment decisions can be made. Outcomes will be compared with those of conventional management without ICG to clarify whether the use of ICG improves the success rate of testicular preservation and reduces unnecessary orchiectomy and reoperations. Furthermore pathological re evaluation of removed testes will be performed to assess the appropriateness of intraoperative surgical judgment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The outcomes of this study will be evaluated by assessing the presence or absence of testicular blood flow intraoperatively using indocyanine green ICG fluorescence imaging and determining whether the affected testis could be preserved. The ICG based perfusion assessment will be compared with the surgeons conventional macroscopic intraoperative evaluation to analyze any concordance or discrepancy in the decision to preserve or remove the testis. In addition the postoperative course of preserved testes will be followed to assess the occurrence of testicular atrophy and to determine whether ICG based blood flow evaluation contributes to more appropriate decisions regarding testicular preservation. Furthermore histopathological evaluation of removed testes will be performed to verify the appropriateness of the intraoperative surgical judgment.
Key secondary outcomes
As a secondary outcome, testes preserved based on intraoperative assessment will be followed for two years after surgery. During the follow-up period, periodic ultrasonographic examinations will be performed to evaluate the presence and adequacy of intratesticular blood flow, as well as changes in testicular volume. These assessments will be used to determine whether adequate perfusion is maintained and whether testicular atrophy occurs in the preserved testes, thereby allowing evaluation of the appropriateness of the intraoperative blood flow assessment and the decision to preserve the testis.
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
| Medicine |
Interventions/Control_1
Indocyanine Green (ICG)
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
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male
Key inclusion criteria
1 Subjects aged 0 years or older and younger than 16 years at the time of obtaining consent
2 Subjects who received sufficient explanation regarding participation in this study and from whom written informed consent was obtained based on the free will of the subject or the subjects guardian after adequate understanding
Key exclusion criteria
1 Cases judged to be inappropriate for inclusion by the operating surgeon even if consent from the subject and the subjects family has been obtained
2 Patients judged to be inappropriate as study subjects by the principal investigator for other reasons
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Mikami |
Organization
Juntendo University Urayasu Hospital
Division name
Pediatric Surgery
Zip code
2790021
Address
2-1-1 Tomioka Urayasu Chiba Japan
TEL
0473533111
t-mikami@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Iida |
Organization
Juntendo University Hospital
Division name
Pediatric Surgery
Zip code
1138431
Address
3-1-3 Hongo Bunkyo Tokyo Japan
TEL
0338133111
Homepage URL
h.kondo.qq@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Pediatric Surgery Research Grant
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3 Hongo Bunkyo Tokyo Japan
Tel
0338133111
h.kondo.qq@juntendo.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
| 2026 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
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 | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2026 | Year | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069712
