UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036214
Receipt No. R000041255
Scientific Title Preliminary study of contrast enhanced ultrasonography using sonazoid and forward-viewing endoscopic ultrasonography for the colorectal disease
Date of disclosure of the study information 2019/03/15
Last modified on 2019/03/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Preliminary study of contrast enhanced ultrasonography using sonazoid and forward-viewing endoscopic ultrasonography for the colorectal disease
Acronym Contrast enhanced EUS for colorectal disease
Scientific Title Preliminary study of contrast enhanced ultrasonography using sonazoid and forward-viewing endoscopic ultrasonography for the colorectal disease
Scientific Title:Acronym Contrast enhanced EUS for colorectal disease
Region
Japan

Condition
Condition colorectal disease
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 usefulness of contrast enhanced EUS for colorectal disease
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnosability of colorectal disease
Key secondary outcomes

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
Device,equipment
Interventions/Control_1 EUS, which is approved for only upper GI diseases, is used for colorectal diseases.
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
95 years-old >=
Gender Male and Female
Key inclusion criteria 1 known or suspected colorectal disease
2 colonoscopy scheduled or colonoscopy found colorectal disease
Key exclusion criteria A.age limitations
B.allergy for rubber
C.incomplete informed consent
D.pregnant
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Yamamura
Organization Nagoya university hospital
Division name Department of Endoscopy
Zip code 4668550
Address 65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL 0527412172
Email tyamamu@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Masaya
Middle name
Last name Esaki
Organization Nagoya university hospital
Division name Department of Endoscopy
Zip code 4668550
Address 65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL 0527412172
Homepage URL
Email em6089@med.nagoya-u.ac.jp

Sponsor
Institute Department of Endoscopy, Nagoya university hospital
Institute
Department

Funding Source
Organization Department of Endoscopy, 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 Institution Review Board of Nagoya university
Address 65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
Tel 0527412172
Email 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

Other administrative information
Date of disclosure of the study information
2019 Year 03 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
2018 Year 01 Month 01 Day
Date of IRB
2016 Year 01 Month 29 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2020 Year 03 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
2019 Year 03 Month 15 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041255

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.