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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007890
Receipt No. R000009293
Scientific Title An in vivo pilot study to determine the optimal staining regimen for colonic endocytescopy
Date of disclosure of the study information 2012/05/04
Last modified on 2014/12/17

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Basic information
Public title An in vivo pilot study to determine the optimal staining regimen for colonic endocytescopy
Acronym Staining regimen for colonic endocytescopy
Scientific Title An in vivo pilot study to determine the optimal staining regimen for colonic endocytescopy
Scientific Title:Acronym Staining regimen for colonic endocytescopy
Region
Japan

Condition
Condition Normal rectal mucosa
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the optimal staining regimen for colonic endocytscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Optimal staining regimen.
Key secondary outcomes Validity of the study.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Diagnosis
Type of intervention
Medicine Maneuver
Interventions/Control_1 Endocytoscopic examination for normal rectal mucosa staining with 1% methylene blue(10ml)
Interventions/Control_2 Endocytoscopic examination for normal rectal mucosa staining with 0.05% crystal violet(10ml)
Interventions/Control_3 Endocytoscopic examination for normal rectal mucosa staining with 1% toluidine blue(10ml)
Interventions/Control_4 Endocytoscopic examination for normal rectal mucosa staining with 1% methylene blue(5ml)+0.05% crystal violet(5ml)
Interventions/Control_5 Endocytoscopic examination for normal rectal mucosa staining with 1% toluidine blue(5ml)+0.05% crystal violet(5ml)
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)patients with recal polyps
(2)Over 20 years old
(3)Written informed consent
Key exclusion criteria Inflammatory bowel disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuro Ichimasa
Organization Showa University, Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL 045-949-7000
Email ichitommy14@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuro Ichimasa
Organization Showa University, Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL 045-949-7000
Homepage URL
Email ichitommy14@yahoo.co.jp

Sponsor
Institute Showa University, Northern Yokohama Hospital
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 昭和大学横浜市北部病院

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 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
2012 Year 05 Month 04 Day
Last modified on
2014 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009293

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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