UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027085 |
|---|---|
| Receipt number | R000031046 |
| Scientific Title | The Accuracy and Usability of intraoperative ultrasonography (Real-time Virtual Sonography) for liver surgery |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2017/04/21 14:28:17 |
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Basic information
Public title
The Accuracy and Usability of intraoperative ultrasonography (Real-time Virtual Sonography) for liver surgery
Acronym
RVS study for liver surgery
Scientific Title
The Accuracy and Usability of intraoperative ultrasonography (Real-time Virtual Sonography) for liver surgery
Scientific Title:Acronym
RVS study for liver surgery
Region
| Japan |
Condition
Condition
liver tumor, pancreatic tumor, tumor of biliary system
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the accuracy and clinical usability of RVS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
positional error between CT and IOUS images
Key secondary outcomes
Requiring tim for registration time and others
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | < |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent laparotomy and liver mobilization
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Takamoto |
Organization
Japanese Red Cross Medical Center
Division name
Hepatobiliary-pancreatic and liver transplantation surgery
Zip code
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
0334001311
takamoto@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Takamoto |
Organization
Japanese Red Cross Medical Center
Division name
Hepatobiliary-pancreatic and liver transplantation surgery
Zip code
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
0334001311
Homepage URL
takamoto@nifty.com
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Hitachi Aloka Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
462
Org. issuing International ID_1
none
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本赤十字社医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | 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
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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
nothing paticular
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2017 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031046
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
