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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035747
Receipt No. R000040718
Scientific Title Evaluation of the effectiveness and safety of new mouthpiece (GAGLESS) for upper endoscopic endoscopy
Date of disclosure of the study information 2019/02/05
Last modified on 2019/02/01

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Basic information
Public title Evaluation of the effectiveness and safety of new mouthpiece (GAGLESS) for upper endoscopic endoscopy
Acronym Evaluation of the effectiveness and safety of new mouthpiece (GAGLESS) for upper endoscopic endoscopy
Scientific Title Evaluation of the effectiveness and safety of new mouthpiece (GAGLESS) for upper endoscopic endoscopy
Scientific Title:Acronym Evaluation of the effectiveness and safety of new mouthpiece (GAGLESS) for upper endoscopic endoscopy
Region
Japan

Condition
Condition Patients undergoing upper gastrointestinal endoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effectiveness of a newly developed mouthpiece GAGLESS) for upper gastrointestinal endoscopy examination for patients undergoing upper gastrointestinal endoscopy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of pain level of upper gastrointestinal endoscopy as measured by Visual Analogue Scale (VAS)
Key secondary outcomes The examination time, the presence or absence of the past endoscopic examination history, the degree of the success of the procedure, the ease of insertion of the endoscope, the comparison between the blood pressure before and after examination and SpO2 and pulse, the diagnosis of endoscopy, the diagnosis of incidental disease Presence (accompanying endoscope insertion)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
90 years-old >=
Gender Male
Key inclusion criteria 1) Male aged 20 years or older at the time of consent acquisition
2) Patients undergoing upper gastrointestinal endoscopy
Key exclusion criteria 1) Persons who can not obtain consent from this research
2) Others that the research researcher judged unsuitable as the research subject
Target sample size 90

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name ikebuchi yuichiro
Organization Faculty of Medicine, Tottori University
Division name Department of Multidisciplinary Internal Medicine
Zip code
Address Tottori-ken, yonago-shi, nishi-machi 36-1
TEL 0859386527
Email ikebu@tottori-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name ikebuchi yuichiro
Organization Faculty of Medicine, Tottori University
Division name Department of Multidisciplinary Internal Medicine
Zip code
Address Tottori-ken, yonago-shi, nishi-machi 36-1
TEL 0859386527
Homepage URL
Email ikebu@tottori-u.ac.jp

Sponsor
Institute Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization Faculty of Medicine, Tottori University
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
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 鳥取大学医学部附属病院、安来市立病院

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 05 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluate the effectiveness of a newly developed mouthpiece for upper gastrointestinal endoscopy examination for patients undergoing upper gastrointestinal endoscopy.

Management information
Registered date
2019 Year 02 Month 01 Day
Last modified on
2019 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040718

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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