UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014861 |
|---|---|
| Receipt number | R000017268 |
| Scientific Title | The utility and safety of intraperitoneal administration by microbubble agents for cirrhosis with refractory ascites |
| Date of disclosure of the study information | 2014/08/15 |
| Last modified on | 2014/08/14 13:13:14 |
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Basic information
Public title
The utility and safety of intraperitoneal administration by microbubble agents for cirrhosis with refractory ascites
Acronym
Intraperitoneal administration by microbubble agents for refractory ascites
Scientific Title
The utility and safety of intraperitoneal administration by microbubble agents for cirrhosis with refractory ascites
Scientific Title:Acronym
Intraperitoneal administration by microbubble agents for refractory ascites
Region
| Japan |
Condition
Condition
Cirrhosis with refractory ascites
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety of intraperitoneal administration by microbubble contrast agents
Basic objectives2
Others
Basic objectives -Others
Clarification of disease for refractory ascites
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The safety of intraperitoneal administration by microbubble contrast agents
Key secondary outcomes
Transit time to circulation of blood from the time of intraperitoneal administration by microbubble contrast agents
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
Contrast-enhanced ultrasound
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
Cirrotic patients with refractory ascites
Key exclusion criteria
･Child-Pugh grade C
･Egg allergy
･Spontaneous bacterial peritonitis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Maruyama |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Gastroenterology and Nephrology
Zip code
Address
1-8-1, Inohana, Chuou-ku, Chiba, Japan
TEL
043-226-2083
maru-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Sekimoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Gastroenterology and Nephrology
Zip code
Address
1-8-1, Inohana, Chuou-ku, Chiba, Japan
TEL
043-226-2083
Homepage URL
tad_sekimoto@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology
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
| 2014 | Year | 08 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 15 | 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
| 2014 | Year | 08 | Month | 14 | Day |
Last modified on
| 2014 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017268
