UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011571 |
|---|---|
| Receipt number | R000013533 |
| Scientific Title | Evaluation of efficacy of real-time virtual sonography for abdonminal ultrasonocgraphy |
| Date of disclosure of the study information | 2013/08/23 |
| Last modified on | 2019/04/04 00:33:13 |
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Basic information
Public title
Evaluation of efficacy of real-time virtual sonography for abdonminal ultrasonocgraphy
Acronym
Evaluation of efficacy of real-time virtual sonography for abdonminal ultrasonocgraphy
Scientific Title
Evaluation of efficacy of real-time virtual sonography for abdonminal ultrasonocgraphy
Scientific Title:Acronym
Evaluation of efficacy of real-time virtual sonography for abdonminal ultrasonocgraphy
Region
| Japan |
Condition
Condition
Patients suffering from gastrointestinal diseases
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of real time virtual sonography (RVS) for the abdominal ultrasonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to detect ascending, descending colon, ileocecal part, appendix and known disease resions
Key secondary outcomes
Percentage to detect ascending, descending colon, ileocecal part, appendix and known disease resions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Using RVS
Interventions/Control_2
Not using RVS
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
1) In and out patients with gastrointestinal diseases in Osaka University hospital
2) Patients require investigation of GI tract (e.g., inflammatory bowel disease, colon cancer, etc)
3) Patients performed abdominal CT scan within 6 months
4) Aged over 20 years old
5) Agreement on informed concent
Key exclusion criteria
1) Patients performed resection of GI tract after CT scan
2) Patients who are not considered suitable by doctors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Iijima |
Organization
Osaka University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
5650871
Address
2-15 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
hiijima@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | IIjima |
Organization
Osaka University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
5650871
Address
2-15 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka University Hospital
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
Osaka University Hospital
Address
2-15 Yamadaoka, Suita, Osaka, Japan
Tel
0668795111
hiijima@gh.med.osaka-u.ac.jp
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
| 2013 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
http://www.med.osaka-u.ac.jp/pub/gh/
Publication of results
Unpublished
Result
URL related to results and publications
Journal of Gastroenterology and Hepatology accepted for publication
Number of participants that the trial has enrolled
27
Results
Examination time to scan the ascending colon and the ileocecum using RVS was significantly shorter than that using conventional US alone. in participants without intestinal diseases. Well-synchronized US images of the intestinal lesions, such as stenosis, with reference CT/MR images were obtained by RVS in all the lesions in the fixed parts of the colon and images of 9 lesions in 12 lesions (75%) were well synchronized in the unfixed part of the intestine in Crohn's disease patients.
Results date posted
| 2019 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
20 IBD patients
7 patients with unrelated to intestinal diseases
Participant flow
Patients who agreed to participate in this study were recruited in Osaka University Hospital
Adverse events
None
Outcome measures
The time to scan 3 parts of the large intestine (the descending colon, ascending colon, and ileocecum) with RVS was compared to that using conventional US.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013533
