UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013615 |
|---|---|
| Receipt number | R000015902 |
| Scientific Title | Usefulness of a novel nasal anesthesia technique: prospective randomized comparison to a conventional technique |
| Date of disclosure of the study information | 2014/04/03 |
| Last modified on | 2015/04/03 13:55:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Usefulness of a novel nasal anesthesia technique: prospective randomized comparison to a conventional technique
Acronym
A novel nasal anesthesia technique
Scientific Title
Usefulness of a novel nasal anesthesia technique: prospective randomized comparison to a conventional technique
Scientific Title:Acronym
A novel nasal anesthesia technique
Region
| Japan |
Condition
Condition
Screening of upper gastrointestinal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between our original new nasal anesthesia and a conventional technique
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time for nasal anesthesia (usability assesment)
Severity of nasal pain and nasal injury(equivalence assesment)
Key secondary outcomes
Overall acceptability(equivalence assesment)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
A novel nasal anesthesia
Interventions/Control_2
A conventional technique
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients of screening for upper gastrointestinal disease
Key exclusion criteria
Patients who need emergency or endoscopic therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Mori |
Organization
Ichinomiya Nishi Hospital
Division name
Department of gastroenterology
Zip code
Address
1 Hira Kaimei Ichinomiya Aichi Japan
TEL
0586-48-0077
a-mori@anzu.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Mori |
Organization
Ichnomiya Nishi Hospital
Division name
Depatement of gastroenterology
Zip code
Address
1 Hira Kaimei Ichinomiya Aichi Japan
TEL
0586-48-0077
Homepage URL
a-mori@anzu.or.jp
Sponsor or person
Institute
Ichnomiya Nishi Hospital
Institute
Department
Personal name
Funding Source
Organization
Ichnomiya Nishi Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 03 | Day |
Last modified on
| 2015 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015902
