UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015014 |
|---|---|
| Receipt number | R000017342 |
| Scientific Title | The investigation for the usefulness of the newly developed Fujifilm US observation apparatus (SU-1). |
| Date of disclosure of the study information | 2014/09/15 |
| Last modified on | 2019/09/05 11:27:20 |
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Basic information
Public title
The investigation for the usefulness of the newly developed Fujifilm US observation apparatus (SU-1).
Acronym
Nagoya-Fujifilm EUS SU-1 trial
Scientific Title
The investigation for the usefulness of the newly developed Fujifilm US observation apparatus (SU-1).
Scientific Title:Acronym
Nagoya-Fujifilm EUS SU-1 trial
Region
| Japan |
Condition
Condition
Digestive disease, Gastrointestinal Submucosal tumor, Perigastrointestinal lesion, Pancreatobiliary lesion
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of newly developed US observation machine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the quality of ultrasound images,
1)fundamental B mode,2)Color/Power doppler,3)Sound speed correction, 4)Tissue harmonic imaging, 5)Contrast-harmonic mode, 6)Elastography
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who recommended to undergo EUS observation.
e.g.
Digestive disease
GI submucosal tumor
Perigastrointestinal lesion
Pancreatobiliary lesion
Key exclusion criteria
Patients with contraindication for GI endoscopy.
e.g.
Shock status
Perforation of GI tract
Strangulated ileus
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eizaburo |
| Middle name | |
| Last name | ohno |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
4650028
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Eizaburo |
| Middle name | |
| Last name | ohno |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
4650028
Address
65 tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2602
Homepage URL
eono@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university institutional review board
Address
65 Tsurumai-cho, Showa-ku
Tel
0527442423
ethics@med.nagoya-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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 09 | Month | 01 | Day |
Other
Other related information
Observation Points
1)Fundamental B mode
2)Color doppler/Power doppler
3)Sound speed correction
4)Tissue harmonic imaging
5)Contrast harmonic imaging
6)Elastography
Management information
Registered date
| 2014 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017342
