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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name