UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036214
Receipt number 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 17:36:41

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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 or person

Institute

Department of Endoscopy, Nagoya university hospital

Institute

Department

Personal name



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

Value
https://center6.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