UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019232 |
|---|---|
| Receipt number | R000022224 |
| Scientific Title | Prospective analysis for the usefulness of a new EBUS-TBNA biopsy needle |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2022/10/10 11:43:22 |
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Basic information
Public title
Prospective analysis for the usefulness of a new EBUS-TBNA biopsy needle
Acronym
NETBN study
Scientific Title
Prospective analysis for the usefulness of a new EBUS-TBNA biopsy needle
Scientific Title:Acronym
NETBN study
Region
| Japan |
Condition
Condition
enlarged mediastinal lymph nodes
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the usefulness of a new EBUS-TBNA biopsy needle with that of a conventional one
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy (diagnostic rate)
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Biopsy with a new EBUS-TBNA biopsy needle (Interventions)
Interventions/Control_2
Biopsy with a conventional EBUS-TBNA biopsy needl (Control)
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
The patient whom mediastinal lymph node puncture biopsy is necessary for a diagnosis or a treatment orientation
Key exclusion criteria
Patients without indication of EBUS-TBNA examination
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Munakata |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1360
munakata@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Kanazawa |
Organization
Fukushima Medical University Hospital
Division name
Department of Pulmonary Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1360
Homepage URL
k-kenya@fmu.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine, Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pulmonary Medicine, Fukushima Medical University School of Medicine
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
Fukushima Medical University School of Medicine
Address
1-Hikarigaoka, Fukushima
Tel
0245471360
k-kenya@fmu.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
福島県立医科大学附属病院呼吸器内科（福島県）／Department of Pulmonary medicine, Fukushima Medical University Hospital (Fukushma)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
no releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
no publication
Number of participants that the trial has enrolled
22
Results
The study was over.
Results date posted
| 2022 | Year | 10 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with indication of EBUS-TBNA.
Participant flow
Patients received the explanation of EBUS-TBNA before the broncoscopic examnation.
Adverse events
No adverse event
Outcome measures
The diagnostic rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 26 | 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 | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022224
