UMIN-CTR Clinical Trial

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
Institute	Oita San-ai Medical Center
Institute
Department

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
URL(English)	https://upload.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

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