UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027874 |
|---|---|
| Receipt number | R000031940 |
| Scientific Title | Evaluation of the usefulness of preoperative 3D simmulation in partial nephrectomy -using ICG ( indocyanine green ) fluorescence Imaging |
| Date of disclosure of the study information | 2017/06/22 |
| Last modified on | 2023/06/28 15:58:14 |
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Basic information
Public title
Evaluation of the usefulness of preoperative 3D simmulation in partial nephrectomy
-using ICG ( indocyanine green ) fluorescence Imaging
Acronym
ICG fluorescence imaging in partial nephrectomy
Scientific Title
Evaluation of the usefulness of preoperative 3D simmulation in partial nephrectomy
-using ICG ( indocyanine green ) fluorescence Imaging
Scientific Title:Acronym
ICG fluorescence imaging in partial nephrectomy
Region
| Japan |
Condition
Condition
renal tumor
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of 3D simulation in partial nephrectomy by using ICG fluorescence Imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
validation of the expected feeding artery
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
| Medicine |
Interventions/Control_1
intravenous administration of ICG ( indocyanine green)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) PS 0 or 1
2) 20 years old over at the acquisition of the consent
3) no severe abnormality of cardioplumonary, liver and renal function
4) contrast CT is performed
5) no contraindication of administration of ICG
6) the written consent of the patient has been obtained for this clinical trial
Key exclusion criteria
When there is request of the cancellation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yoshida |
Organization
Shiga university of medical science
Division name
department of urology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL
077-548-2273
hquro@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yoshida |
Organization
Shiga university of medical science
Division name
department of urology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL
077-548-2273
Homepage URL
hquro@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga university of medical science
Institute
Department
Personal name
Funding Source
Organization
Shiga university of medical science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Urology Shiga University of Medical science
Address
Seta Tukinowa chou, Otsu, Shiga, Japan
Tel
+819078803956
hquro@belle.shiga-med.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
| 2017 | Year | 06 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
