UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040353
Receipt number R000046029
Scientific Title Endoscopy is an aerosol generating procedure; quantitative proof
Date of disclosure of the study information 2020/05/11
Last modified on 2020/05/26 12:47:56

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Examination in COVID-19 pandemic; Whether endoscopies really generate aerosol particles?

Acronym

Generation of aerosol by endoscopy

Scientific Title

Endoscopy is an aerosol generating procedure; quantitative proof

Scientific Title:Acronym

Endoscopy is an aerosol generating procedure; quantitative proof

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination whether endoscopies produce earosol.

Basic objectives2

Others

Basic objectives -Others

Relation ship between the factors about endoscopic procedure and the amount of aerosol.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To assess the change of aerosol particle number at each time phase before, during, and after endoscopy and compare the trend of change of aerosol number in the situation of endoscopy and control group.

Key secondary outcomes

To analyze the relevance between patient characteristics, procedure related factors and increase or decrease of aerosol particles during endoscopy


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit

95 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who undergo endoscopy during the study period.
Patients who agree the informed consent.

Key exclusion criteria

Patients who do not agree the informed consent.
Patients who can not complete the examination due to body movement or respiratory deterioration.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Sagami

Organization

Oita San-ai Medical Center

Division name

Department of Gastroenterology

Zip code

870-1151

Address

Oaza Ichi 1213, Oita, Oita, Japan.

TEL

+81-97-541-1311

Email

sagami1985@yahoo.co.jp


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Sagami

Organization

Oita San-ai Medical Center

Division name

Department of Gastroenterology

Zip code

870-1151

Address

Oaza Ichi 1213, Oita, Oita, Japan.

TEL

+81-97-541-1311

Homepage URL


Email

sagami1985@yahoo.co.jp


Sponsor or person

Institute

Oita San-ai Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Oita San-ai Medical Center

Address

Oaza Ichi 1213, Oita, Oita, Japan.

Tel

+81-97-541-1311

Email

sagami1985@yahoo.co.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

大分三愛メディカルセンター


Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 11 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

Terminated

Date of protocol fixation

2020 Year 05 Month 08 Day

Date of IRB

2020 Year 05 Month 08 Day

Anticipated trial start date

2020 Year 05 Month 11 Day

Last follow-up date

2020 Year 05 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Measurement of the amount of aerosol before and after endoscopy by handheld particle counter model 3889.


Management information

Registered date

2020 Year 05 Month 11 Day

Last modified on

2020 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046029


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name