UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042939
Receipt number 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 2022/01/21 16:38:05

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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 or person

Institute

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

Institute

Department

Personal name



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

Completed

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

2021 Year 12 Month 31 Day

Date trial data considered complete

2021 Year 12 Month 31 Day

Date analysis concluded

2021 Year 12 Month 31 Day


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

2022 Year 01 Month 21 Day



Link to view the page

Value
https://center6.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