UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040815 |
|---|---|
| Receipt number | R000046554 |
| Scientific Title | A pilot study for novel infection prevention mask during esophagogastroduodenoscopy |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2022/10/28 16:04:16 |
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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
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
mego@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046554
