UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047848 |
|---|---|
| Receipt number | R000054552 |
| Scientific Title | Comparison of breathing methods in conventional endoscopy: a prospective randomized controlled trial |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2024/04/29 14:16:11 |
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Basic information
Public title
Comparison of breathing methods in conventional endoscopy: a prospective randomized controlled trial
Acronym
breathing methods in conventional endoscopy
Scientific Title
Comparison of breathing methods in conventional endoscopy: a prospective randomized controlled trial
Scientific Title:Acronym
breathing methods in conventional 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 transoral endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient tolerance and endoscopic operability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
oral breathing
Interventions/Control_2
nasal breathing
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) patients aged 20 or above
ii) those willing to undergo transoral endoscopy
iii) those who agreed to give their written informed consent
Key exclusion criteria
i) patients who were willing to undergo sedation-assisted endoscopy
ii) patients who had a scheduled therapeutic intervention
iii) patients with a history of upper gastrointestinal surgery
iv) patients who refused to provide written informed consent
Target sample size
126
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
| 2022 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054552
