UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035887
Receipt No. R000040890
Scientific Title An exploratory study on the relation between the detection of chest/abdominal wall vein and liver reserve or esophageal varices using cellphone application Vein Seek.
Date of disclosure of the study information 2019/02/15
Last modified on 2019/02/15

* 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 An exploratory study on the relation between the detection of chest/abdominal wall vein and liver reserve or esophageal varices using cellphone application Vein Seek.
Acronym An exploratory study on the detection of chest/abdominal wall vein.
Scientific Title An exploratory study on the relation between the detection of chest/abdominal wall vein and liver reserve or esophageal varices using cellphone application Vein Seek.
Scientific Title:Acronym An exploratory study on the detection of chest/abdominal wall vein.
Region
Japan

Condition
Condition chronic liver disease, liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate the degree of the abdominal wall vein of patients with liver cirrhosis by using the application for blood vessel image enhancement and analyze its clinical meaning.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ability of Vein Seek on detecting chest wall and abdominal wall vein of cirrhotic patients.
Key secondary outcomes 1) Correlation with hepatic reserve (Child-Pugh classification)
2) Correlation with clinical images (endoscopic examination, CT images, MRI images)

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

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients, regardless of hospitalization or outpatient, who meet either of the following criteria are targeted.
1) Subjects who are clinically suspected of chronic liver disease; it is selected to investigate from which stage of liver disease chest wall / abdominal wall vein can be detected.
2) Subjects who have already been confirmed to have cirrhosis.
Key exclusion criteria Patients who conflict with the following will not be included in this clinical study.
1) Subjects who have skin lesions and are difficult to acquire images.
2) Subjects who the researcher judged unsuitable for this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaaki Sugihara
Organization Tottori University Hospital
Division name Department of Gastroenterology
Zip code
Address 36-1, Nishi-cho, Yonago city, Tottori prefecture, Japan, 683-8504,
TEL 0859386527
Email sugitaka@tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Sugihara
Organization Tottori University Hospital
Division name Department of Gastroenterology
Zip code
Address 36-1, Nishi-cho, Yonago city, Tottori prefecture, Japan, 683-8504,
TEL 0859386527
Homepage URL
Email sugitaka@tottori-u.ac.jp

Sponsor
Institute School of Medicine, Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization School of Medicine, Tottori University Faculty of Medicine
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
Address
Tel
Email

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 02 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information now enrolling

Management information
Registered date
2019 Year 02 Month 15 Day
Last modified on
2019 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.