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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036922
Receipt No. R000042074
Scientific Title A prospective randomized trial of acceptability, safety and feasibility comparing transnasal and peroral ultrathin endoscopy using GAGLESS mouthpieces
Date of disclosure of the study information 2019/06/02
Last modified on 2019/06/02

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Basic information
Public title A prospective randomized trial of acceptability, safety and feasibility comparing transnasal and peroral ultrathin endoscopy using GAGLESS mouthpieces
Acronym A prospective randomized trial of acceptability, safety and feasibility comparing transnasal and peroral ultrathin endoscopy using GAGLESS mouthpieces
Scientific Title A prospective randomized trial of acceptability, safety and feasibility comparing transnasal and peroral ultrathin endoscopy using GAGLESS mouthpieces
Scientific Title:Acronym A prospective randomized trial of acceptability, safety and feasibility comparing transnasal and peroral ultrathin endoscopy using GAGLESS mouthpieces
Region
Japan

Condition
Condition gastrointestinal disease
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For patients undergoing upper gastrointestinal endoscopy, we will evaluate the efficacy of the newly developed upper gastrointestinal endoscopy mouthpiece.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain severity of upper gastrointestinal endoscopy measured by Visual Analogue Scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Oral endoscopy using commercially available GAGLESS mouthpieces
Interventions/Control_2 Transnasal endoscopy
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
120 years-old >
Gender Male
Key inclusion criteria 1) Men who are 20 years of age or older at the time of obtaining consent
2) Patients who undergo upper gastrointestinal endoscopy for the first time
Key exclusion criteria 1) Those who can not obtain the consent of this research
2) In addition, those who were judged as inappropriate for study by the research investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kazuya
Middle name
Last name Matsumoto
Organization Medical corporation Irisawa Medical Clinic
Division name Internal Medicine
Zip code 6900025
Address 285-6, Yawata-cho, Matsue 690-0025
TEL 0852-38-8211
Email matsumotokazuya@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name Kazuya
Middle name
Last name Matsumoto
Organization Medical corporation Irisawa Medical Clinic
Division name Internal Medicine
Zip code 6900025
Address 285-6, Yawata-cho, Matsue 690-0025
TEL 0852-38-8211
Homepage URL
Email matsumotokazuya@med.tottori-u.ac.jp

Sponsor
Institute Medical corporation Irisawa Medical Clinic
Institute
Department

Funding Source
Organization Medical corporation Irisawa Medical Clinic
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 Yasugi Municipal Hospital
Address 1931, Hirose, Hirose-cho, Yasugi 692-0404
Tel 0854-32-2121
Email yasugihp@mx.miracle.ne.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
2019 Year 06 Month 02 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
2019 Year 04 Month 23 Day
Date of IRB
2019 Year 05 Month 27 Day
Anticipated trial start date
2019 Year 06 Month 03 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 02 Day
Last modified on
2019 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042074

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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