UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Acronym	Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Scientific Title	Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Scientific Title:Acronym	Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Four-Dimensional Phase-Contrast Vastly Undersampled Isotropic Projection Reconstruction (PC-VIPR) enables the assessment of hemodynamics of the blood vessels. The purpose of this study is to evaluate the efficacy of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100), and compare with conventional analysis with abdominal ultrasonography (US).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ratio of SMA flow volume at t=25 min to t=-25 min measured by US and PC-VIPR.
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	Prevention
Type of intervention	Medicine
Interventions/Control_1	State of taking daikenchuto(TU-100)
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	1.Healthy adults over 20 years old 2.Systolic blood pressure under 140mmHg 3.Written informed consent
Key exclusion criteria	1. Person with MRI contraindications (claustrophobic, metal in the body, etc.) 2.High blood pressure 3.The past of the heart disease 4.With the history of abdominal surgery 5.Under the medical treatment 6.Disable to keep face up position 7.Pregnant or possibly pregnant 8.Under the nursing
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyotaka Kurachi
Organization	Hamamatsu University School of Medicine
Division name	Surgery 2, Divisions of Gastroenterological & Vascular Surgery
Zip code
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL	053-435-2279
Email	kurachi1@hama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mayu Sakata
Organization	Hamamatsu University School of Medicine
Division name	Surgery 2, Divisions of Gastroenterological & Vascular Surgery
Zip code
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL	053-435-2279
Homepage URL
Email	mayu-s@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	None
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	2017 Year 05 Month 24 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	Completed
Date of protocol fixation	2017 Year 05 Month 11 Day
Date of IRB	2017 Year 05 Month 02 Day
Anticipated trial start date	2017 Year 05 Month 24 Day
Last follow-up date	2018 Year 04 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 24 Day
Last modified on	2020 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031471