UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013857 |
|---|---|
| Receipt number | R000016162 |
| Scientific Title | Usefulness of confocal laser endomicroscopy using fluorescent agents |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2019/05/05 11:41:43 |
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Basic information
Public title
Usefulness of confocal laser endomicroscopy using fluorescent agents
Acronym
Usefulness of confocal laser endomicroscopy
Scientific Title
Usefulness of confocal laser endomicroscopy using fluorescent agents
Scientific Title:Acronym
Usefulness of confocal laser endomicroscopy
Region
| Japan |
Condition
Condition
gastrointestinal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the usefulness and safety of probe-type and needle-type confocal laser endomicroscopy(CLE) for gastrointestinal diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Diagnostic yields of CLE compared with pathological diagnosis using biopsies, endoscopically or surgically resected specimens.
Key secondary outcomes
Adverse events
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with documented or suspected gastrointestinal diseases
Key exclusion criteria
1. Allergy to fluorescent agents
2. General prostration
3. Severe diabetes
4. Severe heart diseases
5. Severe cerebrovascular diseases
6. Cirrhosis
7. Pheochomocytoma
8. Bleeding tendency
9. Pregnant
10. Contraindication of endoscopy
11. Other unsuitable cases
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
TEL
0562-93-9240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
TEL
0562-93-9240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
1-98 Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
Tel
0562-93-2139
f-irb@fujita-hu.ac.jp
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
藤田保健衛生大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | 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
197
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 | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To obtain the optical histologic images by administration of fluorescent agents
Management information
Registered date
| 2014 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016162
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
