UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021188 |
|---|---|
| Receipt number | R000024433 |
| Scientific Title | Study to confirm the safty and efficacy of Laparoscopic partial nephrectomy for the small renal cell carcinoma using fluorescence navigation with indocyanine green (ICG) |
| Date of disclosure of the study information | 2016/02/24 |
| Last modified on | 2016/02/24 21:25:51 |
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Basic information
Public title
Study to confirm the safty and efficacy of Laparoscopic partial nephrectomy for the small renal cell carcinoma using fluorescence navigation with indocyanine green (ICG)
Acronym
Laparoscopic partial nephrectomy using fluorescence navigation
Scientific Title
Study to confirm the safty and efficacy of Laparoscopic partial nephrectomy for the small renal cell carcinoma using fluorescence navigation with indocyanine green (ICG)
Scientific Title:Acronym
Laparoscopic partial nephrectomy using fluorescence navigation
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The ain of this study is to evaluate the safety and efficacy of the laparoscopic partial nephrectomy for small renal cancer using fluorescence navigation by indocyanine green (ICG).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Negative rate of the resection margin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous injection of the indocyanine green
Interventions/Control_2
without injection of the indocyanine green
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The patients with the indication of the laparoscopic partial nephrectomy for their small renal cell carcinoma
2) The patients who presents a written agreement that participating in this study
Key exclusion criteria
1) The patients with the bleeding tendency
2) The patients who can not tolerate general
anesthesia with sever hart disease
3) The patients who have previous abdominal
surgery which interfere this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyasu Kawai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Nephro-urology
Zip code
Address
1 kawasumi, Mizuho-cho, Mizuho-ku, nagoya, Japan
TEL
052-853-8266
n-kawai@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyasu Kawai |
Organization
Nagoya City University Graduate School
Division name
medical Scienses
Zip code
Address
1 Kawasumi, Mizuho-cho,Mizh\uho-ku, nagoya, Japan
TEL
052-853-8266
Homepage URL
n-kawai@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2016 | Year | 02 | Month | 24 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2016 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024433
