UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Extracorporeal Vacuum Suction System in Upper Gastrointestinal Endoscopy
Acronym	Prevention of aerosol diffusion during upper gastrointestinal endoscopy
Scientific Title	Quantitative Study on Prevention of Aerosol Diffusion by Extracorporeal Vacuum Suction System in Upper Gastrointestinal Endoscopy during Coronavirus disease (COVID-19) pandemic.
Scientific Title:Acronym	Prevention of Aerosol Diffusion by extracorporeal vacuum suction System in Upper Gastrointestinal Endoscopy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effectiveness of an extracorporeal vacuum suction system in reducing aerosols in the endoscopy unit and droplet exposure to the examiner during upper gastrointestinal endoscopy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of six particle sizes (0.3/0.5/1.0/3.0/5.0/10micrometre) before and after endoscopy using an extracorporeal vacuum suction device during upper gastrointestinal endoscopy using a particle counter.
Key secondary outcomes	The surface ATP of the examiner's personal protective equipment (gown surface, goggles, etc.) is compared before and after endoscopy using an ATP lumitester while using an extracorporeal vacuum suction device.

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 upper gastrointestinal endoscopy for health check or 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	80

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	fujihara.shintaro@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.hideki@kagawa-u.ac.jp

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

Funding Source
Organization	Kagawa University, Faculty of Medicine, Department of Gastroenterology and Neurology
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	Kagawa Prefectural Shiratori Hospital
Address	963 Matsubara, Higashikagawa City, Kagawa Prefecture
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	2022 Year 02 Month 01 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	61
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	2021 Year 12 Month 25 Day
Date of IRB	2022 Year 01 Month 25 Day
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2022 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 particle levels before and after endoscopic examinations using a particle counter 2. Quantitative measurement of contamination before and after endoscopy on personal protective equipment of examiners by ATP lumitester

Management information
Registered date	2022 Year 01 Month 30 Day
Last modified on	2022 Year 08 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053364