UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018518 |
|---|---|
| Receipt number | R000021435 |
| Scientific Title | Analyses of lung, airways, and pleural lesions using probe-based confocal laser endomicroscopy |
| Date of disclosure of the study information | 2015/08/15 |
| Last modified on | 2021/08/05 16:44:49 |
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Basic information
Public title
Analyses of lung, airways, and pleural lesions using probe-based confocal laser endomicroscopy
Acronym
pCLE imaging of lung, airways and pleural lesions
Scientific Title
Analyses of lung, airways, and pleural lesions using probe-based confocal laser endomicroscopy
Scientific Title:Acronym
pCLE imaging of lung, airways and pleural lesions
Region
| Japan |
Condition
Condition
Pulmonary and pleural diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to collect real time microscopic imaging data of pulmonary and pleural lesions using pCLE via respiratory endoscopy prospectively. This study also aims at establishment of standard pCLE images of various pulmonary diseases in comparison with chest CT findings and optical microscopic findings.
Basic objectives2
Others
Basic objectives -Others
To analyze pCLE images of various thoracic diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze pCLE images of various thoracic diseases
Key secondary outcomes
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
When performing observation or biopsy via respiratory endoscopy, we would observe and record microstructure images of the lesions via probe-based confocal microscopy (Cellvizio - Alveoflex; Mauna Kea Technologies, Paris, France).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pulmonary or pleural lesions who undergo respiratory endoscopy
Patients who voluntarily provide written informed consent
Key exclusion criteria
Patients with severe respiratory insufficiency who are thought to be inadequate to extend examination time by additional procedures related to pCLE
Patients who are considered ineligible for the study by the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Imaizumi |
Organization
Fujita Health University
Division name
Department of Respiratory Medicine
Zip code
4701192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake
TEL
0562-93-9241
jeanluc@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Imaizumi |
Organization
Fujita Health University
Division name
Department of Respiratory Medicine
Zip code
4701192
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi, Japan
TEL
0562-93-9241
Homepage URL
jeanluc@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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Administrative office of research promotion and support, Fujita Health University
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi Japan
Tel
0562-93-2865
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
藤田保健衛生大学病院 （愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 15 | 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
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021435
