UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023875
Receipt number R000027503
Scientific Title A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease
Date of disclosure of the study information 2018/03/31
Last modified on 2022/03/31 15:35:19

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Basic information

Public title

A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease

Acronym

A development of less invasive dynamic imaging inspection

Scientific Title

A development of less invasive dynamic imaging inspection- respiratory disorder, pulmonary arteriopathy and aortic disease

Scientific Title:Acronym

A development of less invasive dynamic imaging inspection

Region

Japan


Condition

Condition

respiratory disorder, pulmonary arteriopathy and aortic disease

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

development of less invasive dynamic imaging inspection

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

a diameter of pulmonary artery and Aorta, length of rib cage

Key secondary outcomes

clinical usefulness


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

X-ray apparatus

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

The Patient could get the erect position,

Key exclusion criteria

pregnant woman

Target sample size

100


Research contact person

Name of lead principal investigator

1st name AKINAGA
Middle name
Last name SONODA

Organization

Shiga University of Medical Science

Division name

Radiology,

Zip code

5202192

Address

seta tsukinowacho, Otsu, Shiga

TEL

810775482288

Email

akinaga@bells.shiga-med.ac.jp


Public contact

Name of contact person

1st name AKINAGA
Middle name
Last name SONODA

Organization

Shiga Uniceristy of Medical Science

Division name

Radiology

Zip code

5292192

Address

seta tsukinowacho, Otsu, Shiga

TEL

810775482288

Homepage URL


Email

akinaga@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga Uniceristy of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Shiga university of medical science

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

Shiga University of Medical Science

Address

Setastukinowacho, Otsu, Shiga

Tel

+81775483576

Email

hqrec@belle.shiga-med.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



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 31 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

Delay expected

Results Delay Reason

Due to the outbreak of COVID-19 patients, a study for research purposes in our hospitals has been restricted.

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

Preinitiation

Date of protocol fixation

2016 Year 08 Month 28 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry

2024 Year 01 Month 30 Day

Date trial data considered complete

2024 Year 01 Month 30 Day

Date analysis concluded

2024 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2016 Year 08 Month 31 Day

Last modified on

2022 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027503


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name