UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009732 |
|---|---|
| Receipt number | R000011409 |
| Scientific Title | Efficacy of guide sheath suction (catheter suction) method in bronchoscopy |
| Date of disclosure of the study information | 2013/01/09 |
| Last modified on | 2013/07/09 16:24:44 |
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Basic information
Public title
Efficacy of guide sheath suction (catheter suction) method in bronchoscopy
Acronym
Guide sheath suction method
Scientific Title
Efficacy of guide sheath suction (catheter suction) method in bronchoscopy
Scientific Title:Acronym
Guide sheath suction method
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficasy and safety of bronchoscopic guide sheath suction (catheter suction) method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic yields of bronchoscopy
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
guide sheath suction
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. Suspicous case of peripheral lung cancer (not directly bronchoscopical visible)
2. Lesion diameter >= 20 mm.
3. Age >= 20 yo.
4. SpO2 >= 90% in r.a.
5. With written informed consent
Key exclusion criteria
1. Allergy to lidocaine
2. Severe comorbidity
3. Unstable angina, severe hypertension, poor controlled asthma, recent myocardial infarction, severe infection
4. Patient with anticoagulant or antiplatelet which cannot be terminated
5. Pregnant woman
6. Unsuitable patient decided by physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ishida |
Organization
Fukushima Medical University
Division name
Dept Pulmonary Medicine/ Clinical Oncology Center
Zip code
Address
Hikarigaoka 1, Fukushima city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukushima Medical University
Division name
Dept Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
tishida@fmu.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pulmonary Medicine, Fukushima Medical 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
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
| 2013 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 08 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 09 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 09 | Day |
Last modified on
| 2013 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011409
