UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018796 |
|---|---|
| Receipt number | R000021748 |
| Scientific Title | Pilot study evaluating the usefulness of a vascular endoscope in bronchoscopy for peripheral pulmonary lesions |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2018/08/28 10:57:06 |
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Basic information
Public title
Pilot study evaluating the usefulness of a vascular endoscope in bronchoscopy for peripheral pulmonary lesions
Acronym
Pilot study evaluating the usefulness of a vascular endoscope in bronchoscopy for peripheral pulmonary lesions
Scientific Title
Pilot study evaluating the usefulness of a vascular endoscope in bronchoscopy for peripheral pulmonary lesions
Scientific Title:Acronym
Pilot study evaluating the usefulness of a vascular endoscope in bronchoscopy for peripheral pulmonary lesions
Region
| Japan |
Condition
Condition
Peripheral pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to observe bronchus directly involved with the small peripheral pulmonary lesions less than 3 cm in size with the use of a vascular endoscope.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Findings of peripheral pulmonary lesions with the use of a vascular endoscope.
Key secondary outcomes
1. Diagnostic yield on histology specimens.
2. Arrival rate of a vascular endoscope to the lesions.
3. Complications (Safety)
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
Bronchoscopy with the use of a vascular endoscope
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with small peripheral pulmonary lesion less than 3 cm in size.
2. Patients with suspected lung cancer.
3. Bronchus directly involved with the lesion is identified on CT.
4. 20 years old or more
5. Informed consent
Key exclusion criteria
1. Lesions deemed as benign diseases on chest CT
2. Case with serious concomitant medical illness
3. SpO2 less than 90 % with supplemental oxygen
4. Disability of cessation of anticoagulant or antiplatelet.
5. Pregnancy
6. Other clinical difficulties in this trial.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Hanaoka |
Organization
Shinshu University School of Medicine
Division name
The First Department of Internal Medicine
Zip code
Address
3-1-1 Asahi Matsumoto, Nagano
TEL
0263-37-2631
masayuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Kosaka |
Organization
Shinshu University School of Medicine
Division name
The First Department of Internal Medicine
Zip code
Address
3-1-1 Asahi Matsumoto, Nagano
TEL
0263-37-2631
Homepage URL
kosaka@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021748
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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