UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043303 |
|---|---|
| Receipt number | R000049438 |
| Scientific Title | Study on gastrointestinal endoscopy using an endoscopy mask |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/02/12 11:02:16 |
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Basic information
Public title
Study on gastrointestinal endoscopy using an endoscopy mask
Acronym
endoscopy mask
Scientific Title
Study on gastrointestinal endoscopy using an endoscopy mask
Scientific Title:Acronym
endoscopy mask
Region
| Japan |
Condition
Condition
Patients who undergo gastrointestinal endoscopy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on operation of the endoscope and the effect on the patient by wearing the newly developed endoscopy mask during gastrointestinal endoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of adverse events in patients with endoscopy mask during gastrointestinal endoscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
To undergo gastrointestinal endoscopy with an endoscopy mask
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
Patients over 20 years old
Patients who undergo gastrointestinal endoscopy at our hospital
Patients with sufficient respiratory function to undergo gastrointestinal endoscopy
Patients with sufficient hemodynamics to undergo gastrointestinal endoscopy
Patients who understand the research content and have written informed consent
Key exclusion criteria
Patients who are unable to stay at rest during gastrointestinal endoscopy
Patients without consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Furukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2172
kazufuru@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Furukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2172
Homepage URL
kazufuru@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Nagoya University School Medicine Bioethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2111
ethics@med.nagoya-u.ac.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
| 2023 | Year | 01 | 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
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 | 02 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049438
