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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016327
Receipt No. R000017852
Scientific Title Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Date of disclosure of the study information 2015/01/28
Last modified on 2016/01/26

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Basic information
Public title Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Acronym Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Scientific Title Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Scientific Title:Acronym Utility of syngo iFlow in the assessment of Bladder Cancer Treatment
Region
Japan

Condition
Condition Bladder Cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Advanced bladder carcinoma is commonly treated by radical cystectomy. However, at Osaka Medical College (OMC), balloon occluded arterial infusion (BOAI) combined with hemodialysis and radiation therapy (OMC regimen) has been performed, and this method has shown good response rates. Here, we present the analysis of the hemodynamics on BOAI by using the software, syngo iFlow.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes For 30 cases, in BOAI and non-BOAI patterns we analysed the flow of contrast material in the bladder artery, superior gluteal artery, and inferior gluteal artery by using the software, syngo iFlow.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment Maneuver
Interventions/Control_1 Newly developed bladder preservation therapy for bladder cancer using double balloon-occluded-arterial-infusion (BOAI) of an anticancer agent known as OMC (Osaka Medical College) regimen has allowed 83% of the patients to achieve complete response. This study aims to elucidate the quantitative difference in hemodynamics of the bladder arteries between double balloon occluded catheter (D-BOC) and conventional single balloon occluded catheter (S-BOC) in which only proximal balloon is inflated by using syngo iFlow (Siemens Healthcare).
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 Invasive bladder cancer patients aged 20 years or older
Key exclusion criteria The cases that the catheter could not be placed in the right position.
The patients having iodine hypersensitivity.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Narumi
Organization Osaka Medical College
Division name Department of Radiology
Zip code
Address 2-7, Daigakumachi, Takatsuki-City, Osaka
TEL 072-683-1221
Email narumi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyohito Yamamoto
Organization Osaka Medical College
Division name Department of Radiology
Zip code
Address 2-7, Daigakumachi, Takatsuki-City, Osaka
TEL 072-683-1221
Homepage URL
Email rad105@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Siemens Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 01 Month 28 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
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 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
2015 Year 01 Month 25 Day
Last modified on
2016 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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