UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046779 |
|---|---|
| Receipt number | R000053364 |
| Scientific Title | Quantitative Study on Prevention of Aerosol Diffusion by Extracorporeal Vacuum Suction System in Upper Gastrointestinal Endoscopy during Coronavirus disease (COVID-19) pandemic. |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/08/01 09:46:53 |
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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
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
kobara.hideki@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 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053364
