UMIN-CTR Clinical Trial

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
Email	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
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	Faculty of Medicine, Tottori University
Address	Tottori-ken, yonago-shi, nishi-machi 36-1
Tel	0859386527
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040718