UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000016162