UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000011571
Receipt No. 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 (Ver. 6)

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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
Last 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
Email hiijima@gh.med.osaka-u.ac.jp

Public contact
1st 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
Email hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013533