UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The utility and safety of real-time endoscopic-guided mucosal admittance(MA) measurement in patients with inflammatory bowel disease(IBD).
Title of the study (Brief title)	The clinical utility of MA in patients with IBD.
Region	Japan

Condition
Condition	Inflammatory bowel disease (IBD)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The determination of the MA in both healthy control and patients with IBD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The clinical utility of MA in patients with IBD.
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	Device,equipment
Interventions/Control_1	Tissue Conductance Meter
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who are diagnosed ulcerative colitis or crohn's disease. 2. Patients who are older than 18 years old. 3. Patients from whom written informed consent is obtained.
Key exclusion criteria	1.Patients who have a history of pacemaker or ICD implantation. 2. Patients who have a history of electrical device implantation to b rain such as deep brain stimulation. 3. Patients who have severe disorder of cardiovascular, liver or renal function, infection, and hematopoietic organ. 4. Patients who are judged as being inappropriate for this study by their medical doctor.
Target sample size	50

Research contact person
Name of lead principal investigator	Tomoo Nakagawa
Organization	Chiba University Hospital
Division name	Department of gastroenterology
Address	1-8-1 Inohana, Chuo-Ku, Chiba city
TEL	043-222-7171
Email	tom20852@hospital.chiba-u.jp

Public contact
Name of contact person	Tomoo Nakagawa
Organization	Chiba University Hospital
Division name	Department of gastroenterology
Address	1-8-1 Inohana, Chuo-Ku, Chiba city
TEL	043-222-7171
Homepage URL
Email	tom20852@hospital.chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 14 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 14 Day
Anticipated trial start date	2016 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 14 Day
Last modified on	2016 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028573