UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029728
Receipt No. R000033953
Scientific Title Fluorescence-enhanced robot-assisted surgery using indocyanine green
Date of disclosure of the study information 2017/12/01
Last modified on 2018/05/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Inoue Keiji
Organization Kochi Medical School
Division name Department of Urorogy
Zip code
Address Kohasu Oko Nankoku Kochi Japan
TEL 088-880-2402
Email karasima@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Karashima Takashi
Organization Kochi Medical School
Division name Department of Urorogy
Zip code
Address Kohasu Oko Nankoku Kochi Japan
TEL 088-880-2402
Homepage URL
Email karasima@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

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
Address
Tel
Email

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 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
Anticipated trial start date
2017 Year 12 Month 01 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
2017 Year 10 Month 26 Day
Last modified on
2018 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


Contact us.