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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009274
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute School of Medicine, Wakayama Medical University, Department of Gastroenterology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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