UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029728 |
|---|---|
| Receipt number | R000033953 |
| Scientific Title | Fluorescence-enhanced robot-assisted surgery using indocyanine green |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2020/05/11 18:09:01 |
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Basic information
Public title
Fluorescence-enhanced robot-assisted surgery using indocyanine green
Acronym
Robot-assisted surgery using indocyanine green
Scientific Title
Fluorescence-enhanced robot-assisted surgery using indocyanine green
Scientific Title:Acronym
Robot-assisted surgery using indocyanine green
Region
| Japan |
Condition
Condition
Prostate cancer, Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of robot-assisted surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of intraoperative vascular flow and localization of lymph node
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
| 17 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who were judged necessary for ICG fluorescence by preoperative examination and intraoperative findings.
2) Patient who intends to comply with the research implementation plan.
3) Regarding the use of ICG, the patient himself / herself has signed the non-applicable use consent form document.
Key exclusion criteria
1) Children, women who are pregnant or breastfeeding.
2) Patients who are complicated with psychosis or psychiatric symptoms and judged difficult to understand the contents of the trial.
3) Patient with a history of ingredients of the agent or iodine hypersensitivity.
4) A patient with a serious disease condition that the attending physician judges that the trial participation is inappropriate.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Inoue |
Organization
Kochi Medical School
Division name
Department of Urorogy
Zip code
7838505
Address
Kohasu Oko Nankoku Kochi Japan
TEL
088-880-2402
karasima@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Karashima |
Organization
Kochi Medical School
Division name
Department of Urorogy
Zip code
7838505
Address
Kohasu Oko Nankoku Kochi Japan
TEL
088-880-2402
Homepage URL
karasima@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kochi University
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
Ethical Reviewboard of Kochi Medical School
Address
Kohasu Oko Nankoku Kochi Japan
Tel
088-880-2180
rinri21@kochi-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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | 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
Three patients with renal cell carcinoma were entered in the trial.
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033953
| 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 |
