UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044451 |
|---|---|
| Receipt number | R000050780 |
| Scientific Title | a prospective randomized comparison of breath methods in transnasal endoscopy |
| Date of disclosure of the study information | 2021/06/07 |
| Last modified on | 2022/12/27 12:27:27 |
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Basic information
Public title
a prospective randomized comparison of breath methods in transnasal endoscopy
Acronym
breath methods in transnasal endoscopy
Scientific Title
a prospective randomized comparison of breath methods in transnasal endoscopy
Scientific Title:Acronym
a prospective randomized comparison of breath methods in transnasal endoscopy
Region
| Japan |
Condition
Condition
upper gastrointestinal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify the optimal breathing method in transnasal endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient tolerance and endoscope operability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
assignment of breathing methods
Interventions/Control_2
assignment of breathing methods
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
i) age over 20
ii) willingness to undergo a transnasal endoscopy
iii) written informed consent
Key exclusion criteria
i) failure to pass through the nasal cavity
ii) failure to breathe in the assigned way
iii) willingness to undergo a sedated endoscopy
iv) a scheduled therapeutic intervention
v) history of upper gastrointestinal surgery
vi) refusal of written informed consent
Target sample size
198
Research contact person
Name of lead principal investigator
| 1st name | Keitaro |
| Middle name | |
| Last name | Takahashi |
Organization
Asahikawa medical university
Division name
Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2462
ktakaha@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Takahashi |
Organization
Asahikawa medical university
Division name
Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2462
Homepage URL
ktakaha@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical university
Institute
Department
Personal name
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
Asahikawa medical university
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
Tel
0166-68-2462
ktakaha@asahikawa-med.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
| 2021 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/pdf/10.1055/a-1900-6004.pdf
Number of participants that the trial has enrolled
198
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 | 06 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 06 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050780
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
