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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000040353
Receipt No. 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

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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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