UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040936
Receipt number 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 2022/07/07 00:49:41

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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 Hospital

Division name

Digestive surgery

Zip code

113-8603

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

nsakuraz@nms.ac.jp


Public contact

Name of contact person

1st name Nobuyuki
Middle name
Last name Sakurazawa

Organization

Nippon Medical School Hospital

Division name

Digestive surgery

Zip code

113-8603

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

nsakuraz@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



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

hokusoh.ethics.group@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

Completed

Date of protocol fixation

2020 Year 06 Month 04 Day

Date of IRB

2020 Year 06 Month 03 Day

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

2022 Year 07 Month 07 Day



Link to view the page

Value
https://center6.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