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
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
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
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
