UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024825
Receipt number R000028573
Scientific Title The utility and safety of real-time endoscopic-guided mucosal admittance(MA) measurement in patients with inflammatory bowel disease(IBD).
Date of disclosure of the study information 2016/11/14
Last modified on 2016/11/14 17:07:52

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Basic information

Public title

The utility and safety of real-time endoscopic-guided mucosal admittance(MA) measurement in patients with inflammatory bowel disease(IBD).

Acronym

The clinical utility of MA in patients with IBD.

Scientific Title

The utility and safety of real-time endoscopic-guided mucosal admittance(MA) measurement in patients with inflammatory bowel disease(IBD).

Scientific Title:Acronym

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

1st name
Middle name
Last name Tomoo Nakagawa

Organization

Chiba University Hospital

Division name

Department of gastroenterology

Zip code


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

1st name
Middle name
Last name Tomoo Nakagawa

Organization

Chiba University Hospital

Division name

Department of gastroenterology

Zip code


Address

1-8-1 Inohana, Chuo-Ku, Chiba city

TEL

043-222-7171

Homepage URL


Email

tom20852@hospital.chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



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)



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

2016 Year 11 Month 14 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

2016 Year 11 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name