UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017041
Receipt number R000019761
Scientific Title Phase II study of ultrasound video bronchoscope for sampling endobronchial lesions
Date of disclosure of the study information 2015/04/05
Last modified on 2020/04/06 09:21:38

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Basic information

Public title

Phase II study of ultrasound video bronchoscope for sampling endobronchial lesions

Acronym

Ultrasound video bronchoscope for sampling endobronchial lesions

Scientific Title

Phase II study of ultrasound video bronchoscope for sampling endobronchial lesions

Scientific Title:Acronym

Ultrasound video bronchoscope for sampling endobronchial lesions

Region

Japan


Condition

Condition

Endotracheal/endobronchial lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate feasibility of bronchoscopy with an ultrasound video bronchoscope for patients with endobronchial lesions

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Feasibility of bronchoscopy with an ultrasound video bronchoscope

Key secondary outcomes

1. Diagnostic yield
2. Bronchoscopic visibility
3. 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

Endobronchial biopsy with an ultrasound video bronchoscope

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 endobronchial lesions demonstrated on chest CT and requiring biopsy for definitive diagnosis
2. Patients with lesions presumed to be sampled with a bronchoscopic biopsy forceps
3. Patients with lesions presumed to be sampled with a bronchoscopic aspiration needle
4. 20 years or older
5. Informed consent

Key exclusion criteria

1. Lesions obviously favorable for examination with a standard bronchoscope
2. Serious concomitant medical illness
3. SPO2<90% with supplemental oxygen
4. Clear bleeding tendency
5. Pregnancy
6. Other presumed difficulties for patients in this study

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahide Oki

Organization

Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan

TEL

052-951-1111

Email

masahideo@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Masahide Oki

Organization

Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan

TEL

052-951-1111

Homepage URL


Email

masahideo@gmail.com


Sponsor or person

Institute

Nagoya Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

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


Email



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

国立病院機構名古屋医療センター (愛知県)


Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 05 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 03 Month 25 Day

Date of IRB

2015 Year 03 Month 26 Day

Anticipated trial start date

2015 Year 04 Month 06 Day

Last follow-up date

2021 Year 02 Month 28 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 04 Month 03 Day

Last modified on

2020 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019761


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name