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
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
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
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
