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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000040353 |
Receipt No. | R000046029 |
Scientific Title | Endoscopy is an aerosol generating procedure; quantitative proof |
Date of disclosure of the study information | 2020/05/11 |
Last modified on | 2020/05/26 |
Basic information | ||
Public title | Examination in COVID-19 pandemic; Whether endoscopies really generate aerosol particles? | |
Acronym | Generation of aerosol by endoscopy | |
Scientific Title | Endoscopy is an aerosol generating procedure; quantitative proof | |
Scientific Title:Acronym | Endoscopy is an aerosol generating procedure; quantitative proof | |
Region |
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Condition | ||
Condition | COVID-19 | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Examination whether endoscopies produce earosol. |
Basic objectives2 | Others |
Basic objectives -Others | Relation ship between the factors about endoscopic procedure and the amount of aerosol. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | To assess the change of aerosol particle number at each time phase before, during, and after endoscopy and compare the trend of change of aerosol number in the situation of endoscopy and control group. |
Key secondary outcomes | To analyze the relevance between patient characteristics, procedure related factors and increase or decrease of aerosol particles during endoscopy |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who undergo endoscopy during the study period.
Patients who agree the informed consent. |
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Key exclusion criteria | Patients who do not agree the informed consent.
Patients who can not complete the examination due to body movement or respiratory deterioration. |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Oita San-ai Medical Center | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | 870-1151 | ||||||
Address | Oaza Ichi 1213, Oita, Oita, Japan. | ||||||
TEL | +81-97-541-1311 | ||||||
sagami1985@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Oita San-ai Medical Center | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | 870-1151 | ||||||
Address | Oaza Ichi 1213, Oita, Oita, Japan. | ||||||
TEL | +81-97-541-1311 | ||||||
Homepage URL | |||||||
sagami1985@yahoo.co.jp |
Sponsor | |
Institute | Oita San-ai Medical Center |
Institute | |
Department |
Funding Source | |
Organization | None |
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 | Oita San-ai Medical Center |
Address | Oaza Ichi 1213, Oita, Oita, Japan. |
Tel | +81-97-541-1311 |
sagami1985@yahoo.co.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 | 大分三愛メディカルセンター |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Terminated | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Measurement of the amount of aerosol before and after endoscopy by handheld particle counter model 3889. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046029 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |