UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023558 |
|---|---|
| Receipt number | R000027089 |
| Scientific Title | Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study |
| Date of disclosure of the study information | 2016/08/09 |
| Last modified on | 2016/08/09 12:30:52 |
* 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
Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study
Acronym
Evaluation of ulcerative colitis mucosa Linked color imaging LCI
Scientific Title
Evaluation of ulcerative colitis mukcosa using Linked color imaging LCI: single center prospective diagnostic study
Scientific Title:Acronym
Evaluation of ulcerative colitis mucosa Linked color imaging LCI
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Others
Basic objectives -Others
Diagnosability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Comparison of concordance rate with Mayo endoscopic sub score using WLI and LCI
2 Comparison of concordance rate with Reddening grade using WLI and LCI
Key secondary outcomes
1 Comparison of diagnosis with Mayo endoscopic sub score and biopsy using WLI and LCI
2 Comparison of Reddening grade with Mayo endoscopic sub score and biopsy using WLI and LCI
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who has inclusion criteria as follows
1 Ulcerative colitis patient
2 Remission and mild activity
Key exclusion criteria
1 carcinoma
2 acute abdomen
3 severe inflammation
4 pregnant woman
5 poor general condition patients who has risk for performing endoscopy such as ileus perforation of intestine pancreatitis respiratory disorder heart failure acquired hemophilia intestinal stricture large ulcer large tumor
6 ongoing anti coagulation therapy or anti platelet therapy
7 intolerance of polyethylene glycol only for transanal approach
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihito Hirai |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1 Zokumyoin Chikushino Fukuoka
TEL
092-921-1011
syokaki@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutomo Yamasaki |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-1-1 Zokumyoin Chikushino Fukuoka
TEL
092-921-1011
Homepage URL
syokaki@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
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
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
福岡大学筑紫病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is prspective and observational study to check evaluation of ulcerative colitis mucosa using Linked color imaging LCI.
Management information
Registered date
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2016 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027089
