UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035747 |
|---|---|
| Receipt number | 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 | 2021/08/04 10:00:25 |
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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
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Ikebuchi |
Organization
Faculty of Medicine, Tottori University
Division name
Department of Multidisciplinary Internal Medicine
Zip code
6838504
Address
Tottori-ken, yonago-shi, nishi-machi 36-1
TEL
0859386527
ikebu@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Ikebuchi |
Organization
Faculty of Medicine, Tottori University
Division name
Department of Multidisciplinary Internal Medicine
Zip code
6838504
Address
Tottori-ken, yonago-shi, nishi-machi 36-1
TEL
0859386527
Homepage URL
ikebu@tottori-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Tottori University
Institute
Department
Personal name
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
Faculty of Medicine, Tottori University
Address
Tottori-ken, yonago-shi, nishi-machi 36-1
Tel
0859386527
ikebu@tottori-u.ac.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
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
https://www.mdpi.com/2075-4418/11/3/538
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2075-4418/11/3/538
Number of participants that the trial has enrolled
90
Results
Endoscopy was completed in all cases, and no complications were observed. The post-EGD difference in DBP was significantly lower in the GAGLESS group than in the conventional group. The results indicate that GAGLESS mouthpieces had a lower VAS during endoscopy than the conventional mouthpieces, and the changes in blood pressure were smaller with the GAGLESS mouthpiece.
Results date posted
| 2021 | Year | 08 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In all, 90 participants were recruited and divided into two equal-sized groups (the conventional mouthpiece group [Conventional group] and the GAGLESS mouthpiece group [GAGLESS group]) using a randomized number table prepared in advance by a researcher who was not involved in the study.
Participant flow
All patients provided written informed consent before the EGD. Between October 2018 and March 2019, all consecutive patients undergoing EGD at the Tottori University Hospital or Yasugi Municipal Hospital were screened.
Adverse events
none
Outcome measures
The primary endpoint was the severity of pain using the visual analog scale (VAS), and secondary endpoints were examination time, past history of endoscopy, success of the procedure, systolic (SBP) and diastolic (DBP) blood pressure, oxygen saturation, pulse rate before and after EGD, and adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040718
