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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040936
Receipt No. R000046740
Scientific Title Examination of the usefulness of covering the mouthpiece with a medical mask to prevent droplets due to cough from the patient during oral upper gastrointestinal endoscopy
Date of disclosure of the study information 2020/06/29
Last modified on 2020/06/29

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Basic information
Public title Examination of the usefulness of covering the mouthpiece with a medical mask to prevent droplets due to cough from the patient during oral upper gastrointestinal endoscopy
Acronym Examination of the usefulness of medical masks to prevent splashes during oral upper gastrointestinal endoscopy
Scientific Title Examination of the usefulness of covering the mouthpiece with a medical mask to prevent droplets due to cough from the patient during oral upper gastrointestinal endoscopy
Scientific Title:Acronym Examination of the usefulness of medical masks to prevent splashes during oral upper gastrointestinal endoscopy
Region
Japan

Condition
Condition Upper gastrointestinal disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the reduction of droplets by using a medical mask during oral upper gastrointestinal endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Degree of droplets during oral upper gastrointestinal endoscopy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Normal oral upper gastrointestinal endoscopy with medical mask
Interventions/Control_2 Normal oral upper gastrointestinal endoscopy without medical mask
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients in need of oral upper gastrointestinal endoscopy
Key exclusion criteria Sedation cases are excluded because cough reflex is reduced
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Sakurazawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Surgery/Digestive surgery
Zip code 270-1694
Address 1715 Kamagari, Inzai-city, Chiba
TEL 0476-99-1111
Email nsakuraz@nms.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Sakurazawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Surgery/Digestive surgery
Zip code 270-1694
Address 1715 Kamagari, Inzai-city, Chiba
TEL 0476-99-1111
Homepage URL
Email nsakuraz@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Nippon Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nippon Medical School Chiba Hokusoh Hospital
Address 1715 Kamagari, Inzai-city, Chiba
Tel 0476-99-1111
Email nsakuraz@nms.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 Jizan Rinri 2-2
Org. issuing International ID_1 Tsuboi Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 29 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 29 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 29 Day
Last modified on
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046740

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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