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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009759
Receipt No. R000011396
Scientific Title Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Date of disclosure of the study information 2013/02/01
Last modified on 2018/07/17

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Basic information
Public title Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Acronym Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Scientific Title Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Scientific Title:Acronym Pathological evaluation of the intestinal tract with confocal laser endomicroscopy
Region
Japan

Condition
Condition GI epithelial lesions
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Confocal laser endomicroscopy (CLE) is a newly established endoscopic method providing in vivo histology at a subcellular resolution during ongoing endoscopy.
In this study, we will evaluate the safety of the technology and also conduct the CLE analysis of GI epithelial mucosal diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The procedural success rate of the visualization of the structure.
Key secondary outcomes 1) Comparing CLE findings with normal endoscopic findings, magnifying-endoscopic findings and pathological findings
2) Differential diagnosis
3) Image quality assessment. The evaluation criteria are divided into three(poor, almost invisible tissue structure; mild, visible tissue structure with too dark vision; good, clearly visible tissue structure).
4) Adverse events

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Transvenous administration of 10% solution or topical application of 0.1% fluorescein solution will be performed for tissue visualization with CLE. Then, the studied sites will be biopsied and the specimens will be histologically evaluated.
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 with suspected digestive disease such as a gastric carcinoma, gastric adenoma, colon carcinoma, colon adenoma.
Key exclusion criteria 1) Patients not indicated for normal endoscopy
2) History of allergy to fluorescein dye
3) Subjects with a severe comorbidity such as a diabetic disease, cardiovascular, neurologic dysfunction, cirrhosis of the liver, pheochromocytoma and pregnancy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuki Sumiyama
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code
Address 3-25-8, Nishi-Shinbashi, Minato-ku Tokyo
TEL 03-3433-1111(ext.3181)
Email kaz_sum@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masakuni Kobayashi
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code
Address 3-25-8, Nishi-Shinbashi, Minato-ku Tokyo
TEL 03-3433-1111(ext.3181)
Homepage URL
Email masakuni@jikei.ac.jp

Sponsor
Institute Department of Endoscopy
The Jikei University School of Medicine
Institute
Department

Funding Source
Organization nothing
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 東京慈恵会医科大学附属病院 内視鏡科

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 01 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
2012 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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
2013 Year 01 Month 11 Day
Last modified on
2018 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011396

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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