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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010571
Receipt No. R000012364
Scientific Title Evaluation of the diagnosis ability by the surface extended observation of colorectal neoplastic lesions using the laser beam endoscope
Date of disclosure of the study information 2013/04/23
Last modified on 2013/04/23

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Basic information
Public title Evaluation of the diagnosis ability by the surface extended observation of colorectal neoplastic lesions using the laser beam endoscope
Acronym Surface extended observation of colorectal tumor using the laser beam endoscope
Scientific Title Evaluation of the diagnosis ability by the surface extended observation of colorectal neoplastic lesions using the laser beam endoscope
Scientific Title:Acronym Surface extended observation of colorectal tumor using the laser beam endoscope
Region
Japan

Condition
Condition Colorectal neoplastic lesions
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To weight BLI endoscope imaging and chromo-endoscopy image for colorectal superficial tumor against the pathologic tissue view after the excision.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare histopathological diagnosis of surgical or endoscopic excision lesion with BLI image diagnosis and then classify endoscope observations corresponding to the pathologic tissue.
Key secondary outcomes To compare pit pattern diagnosis by BLI extended endoscope diagnosis with chromo endoscopy extended observation and then weigh each pathologic diagnosis abilities.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 To diagnosis colorectal tumor by BLI extended endoscope and chromo endoscopy.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with colorectal neoplastic lesions or doubt to colorectal tumor.
Key exclusion criteria 1. Patients with the acute stomach symptom.
2. Patients with the serious acute inflammation.
3. Patients with anaphylaxis to natural rubber.
4. Patients who have the risk of performing endoscopy such as extremely poor condition, ileus, intestinal perforation, respiratory disease and circulatory organ disease.
5. Using pacemaker
6. Patients who are the contraindication case to use of magnesium citrate or Niflec.
7. Patients of frequent colorectal tumor which had participated in this study.
8. Patients disagree with informed consent.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hakuei Shinhata
Organization Jichi Medical University Hospital
Division name Department of Gastroenterology
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken,329-0498 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Osawa
Organization Jichi Medical University Hospital
Division name Department of Gastroenterology
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken,329-0498 Japan
TEL 0285-58-7348
Homepage URL
Email osawa@jichi.ac.jp

Sponsor
Institute Jichi Medical University Hospital
Institute
Department

Funding Source
Organization Fujifilm Corporation
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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 23 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 Open public recruiting
Date of protocol fixation
2013 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 23 Day
Last modified on
2013 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012364

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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