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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013857
Receipt No. 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

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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
Email 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
Email nohmiya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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