UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study for novel infection prevention mask during esophagogastroduodenoscopy
Acronym	A pilot study for novel infection prevention mask during esophagogastroduodenoscopy
Scientific Title	A pilot study for novel infection prevention mask during esophagogastroduodenoscopy
Scientific Title:Acronym	A pilot study for novel infection prevention mask during esophagogastroduodenoscopy
Region	Japan

Condition
Condition	Upper gastrointestinal diseases
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of the mask for the prevention of aerosol exposure mask during esophagogastroduodenoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The prevention of aerosol exposure The range of contamination of sheets outside the infection prevention mask.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients scheduled for EGD and endscopic treatments 2) ECOG Performance status: 0-1 3) Written informed consent obtained from the patient to participate in the study.
Key exclusion criteria	1) Patients with positive PCR test for SARS-CoV-2 2) Patients with suspected SARS-CoV-2 infection 3) The physicians determine that participation in this study is not appropriate.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Seiichiro Middle name Last name Abe
Organization	National Cancer Center Hospital
Division name	Endoscopy
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL	03-3542-2511
Email	seabe@ncc.go.jp

Public contact
Name of contact person	1st name Mai Middle name Last name Ego
Organization	National Cancer Center Hospital
Division name	Endoscopy
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL	03-3542-2511
Homepage URL
Email	mego@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Olympus
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Cancer Center Hospital
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, JAPAN
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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	2020 Year 06 Month 20 Day

Related information
URL releasing protocol	https://www.e-ce.org/journal/view.php?doi=10.5946/ce.2021.178-IDEN
Publication of results	Published

Result
URL related to results and publications	https://www.e-ce.org/journal/view.php?doi=10.5946/ce.2021.178-IDEN
Number of participants that the trial has enrolled	33
Results	The median number of microparticles in volunteers 1, 2, and 3 with and without the aerosol-exposure protection (AP) mask was 8.5 and 110.0, 7.0 and 51.5, and 8.0 and 95.0, respectively (p<0.01). Using the AP mask, microparticles were reduced by approximately 92%. The median distances of microparticle scattering without the AP mask were 60, 0, and 68 in volunteers 1, 2, and 3, respectively. In the 30 patients, the mean SpO2 was 96.3%, and adverse events, such as aspiration pneumonia, were not observed.
Results date posted	2022 Year 10 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy volunteer　3 30 patients undergoing endoscopic treatment for early esophageal cancer and early gastric cancer
Participant flow	Healthy volunteers were afebrile and asymptomatic relating to COVID-19 before the study. Patients undergoing endoscopic resection for superficial esophageal cancer or early gastric cancer, aged >20 years, and their performance status 0-1.
Adverse events	None
Outcome measures	The median number of microparticles in volunteers 1, 2, and 3 with and without the aerosol-exposure protection (AP) mask was 8.5 and 110.0, 7.0 and 51.5, and 8.0 and 95.0, respectively (p<0.01). Using the AP mask, microparticles were reduced by approximately 92%. The median distances of microparticle scattering without the AP mask were 60, 0, and 68 in volunteers 1, 2, and 3, respectively. In the 30 patients, the mean SpO2 was 96.3%, and adverse events, such as aspiration pneumonia, were not observed.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 05 Month 07 Day
Date of IRB	2020 Year 05 Month 07 Day
Anticipated trial start date	2020 Year 05 Month 07 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 06 Month 17 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046554