UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010571 |
|---|---|
| Receipt number | 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 17:05:59 |
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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
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
osawa@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012364
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| Registered date | File name |
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| Registered date | File name |
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