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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042939
Receipt No. R000049014
Scientific Title Efficacy of endobarrier for preventing aerosol transmission of esophagogastroduodenoscopy during COVID-19 pandemic: A quantitative analys
Date of disclosure of the study information 2021/01/10
Last modified on 2021/01/07

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Basic information
Public title Establishment of endobarrier during screening esophagogastroduodenoscopy during COVID-19 pandemic
Acronym Preventing aerosol transmission during esophagogastroduodenoscopy
Scientific Title Efficacy of endobarrier for preventing aerosol transmission of esophagogastroduodenoscopy during COVID-19 pandemic: A quantitative analys
Scientific Title:Acronym Efficacy of endobarrier for preventing aerosol transmission of esophagogastroduodenoscopy: A quantitative analys
Region
Japan

Condition
Condition COVID-19
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study investigated
the efficacy of a specially designed box (Endo barrier) for preventing droplet transmission during esophagogastroduodenoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the change of aerosol particle number before, during, and after endoscopic examination with an Endo barrier
Key secondary outcomes To evaluate the change of adenosine triphosphate (ATP)
bioluminescence assay before, and after endoscopy in the endoscopy unit.

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 undergoing esophagogastroduodenoscopy for health check and screening
Key exclusion criteria 1. Patients who need emergency endoscopic treatment such as gastrointestinal bleeding
2. Patients with psychiatric diseases or psychiatric symptoms who are judged to have difficulty in conducting this clinical trial
3. Patients who the doctor in charge deems inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shintaro
Middle name
Last name Fujihara
Organization Kagawa University, Faculty of Medicine
Division name Department of Gastroenterology and Neurology(Community Medical Care)
Zip code 761-0793
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan
TEL 0878912156
Email joshin@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Kobara
Organization Kagawa University, Faculty of Medicine
Division name Department of Gastroenterology and Neurology
Zip code 761-0793
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan
TEL 0878912156
Homepage URL
Email kobara@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University, Faculty of Medicine, Department of Gastroenterology and Neurology
Institute
Department

Funding Source
Organization Kagawa Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kagawa Prefectural Shiratori Hospital
Address 963 Matsubara, Higashikagawa City, Kagawa Prefecture 769-2788
Tel 087-925-4154
Email shirotoribyoin@pref.kagawa.lg.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
2021 Year 01 Month 10 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 20 Day
Date of IRB
2020 Year 12 Month 22 Day
Anticipated trial start date
2021 Year 01 Month 07 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Measurement of the amount of aerosol before and after endoscopy by handheld particle counter.
2. Measurement of the amount of adenosine triphosphate
bioluminescence assay for monitoring
contamination of the endoscopy unit

Management information
Registered date
2021 Year 01 Month 07 Day
Last modified on
2021 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049014

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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