UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036922 |
|---|---|
| Receipt number | 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 07:45:56 |
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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
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
matsumotokazuya@med.tottori-u.ac.jp
Sponsor or person
Institute
Medical corporation Irisawa Medical Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042074
