UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009274 |
|---|---|
| Receipt number | R000010894 |
| Scientific Title | Usefulness of a continuous suction mouthpiece during peroral double-balloon enteroscopy |
| Date of disclosure of the study information | 2012/11/06 |
| Last modified on | 2012/11/08 22:38:46 |
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Basic information
Public title
Usefulness of a continuous suction mouthpiece during peroral double-balloon enteroscopy
Acronym
Usefulness of a continuous suction mouthpiece during DBE
Scientific Title
Usefulness of a continuous suction mouthpiece during peroral double-balloon enteroscopy
Scientific Title:Acronym
Usefulness of a continuous suction mouthpiece during DBE
Region
| Japan |
Condition
Condition
Small intestine disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A new continuous suction mouthpiece (CSM) was developed, and its usefulness for double-balloon enteroscopy (DBE) was evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Aspiration pneumonia after the double-balloon enteroscopy (DBE) were evaluated.
Key secondary outcomes
Extent of salivary flow, frequency of saliva suction, and number of choking episodes during double-balloon enteroscopy (DBE) were evaluated
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
continuous suction mouthpiece
Interventions/Control_2
conventional type mouthpiece
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with small intestine disease who need double-balloon enteroscopy
Key exclusion criteria
Patients were excluded if they had a history of respiratory problems
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Maekita |
Organization
School of Medicine, Wakayama Medical University
Division name
Department of Gastroenterology
Zip code
Address
811 Kimiidera, Wakayama City, Wakayama 641-0012, Japan
TEL
073-447-2300
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Maekita |
Organization
School of Medicine, Wakayama Medical University
Division name
Department of Gastroenterology
Zip code
Address
811 Kimiidera, Wakayama City, Wakayama 641-0012, Japan
TEL
073-447-2300
Homepage URL
Sponsor or person
Institute
School of Medicine, Wakayama Medical University, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Wakayama Medical University, Department of Gastroenterology
Organization
Division
Category of Funding Organization
Local Government
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
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 06 | 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
| 2012 | Year | 11 | Month | 06 | Day |
Last modified on
| 2012 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010894
