UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope
Acronym	A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope
Scientific Title	A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope
Scientific Title:Acronym	A Prospective Single-center study on Pain Reduction by Peroral EGD Using an ultrathin Endoscope
Region	Japan

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

Objectives
Narrative objectives1	To investigate and evaluate the effect of a transoral endoscopy with an ultrathin endoscope on distress
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Satisfaction compared to conventional diameter transoral upper gastrointestinal endoscopy
Key secondary outcomes	Physician satisfaction with examination, examination time, biopsy site, time taken to biopsy, biopsy success rate, failure to diagnose by pathology, tumor detection rate, and primary endpoint results by skilled and unskilled physicians

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	ultrathin endoscopy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients who are 20 years old or older at the time consent is obtained. (2) Patients have been fully informed about participation in the research, fully understand the circumstances, and consent in writing of his/her own free will.
Key exclusion criteria	(1) Patients who have refused to participate in this study (2) Patients who are considered by the investigator or sub-investigator as not suitable for participation in this study (3) Patients with serious cardiopulmonary diseases or coagulation disorders (4) Patients allergic to Xylocaine (5) Patients who cannot fill out the questionnaire by themselves (6) Patients who have undergone upper gastrointestinal tract surgery (7) Patients with known upper gastrointestinal lesions for which endoscopic or surgical treatment is planned.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name AYA Middle name Last name IWAO
Organization	Nihon University Hospital
Division name	Gastroenterology
Zip code	101-8309
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL	03-3293-1711
Email	iwao.aya@nihon-u.ac.jp

Public contact
Name of contact person	1st name AYA Middle name Last name IWAO
Organization	Nihon University Hospital
Division name	Gastroenterology
Zip code	101-8309
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL	03-3293-1711
Homepage URL
Email	iwao.aya@nihon-u.ac.jp

Sponsor
Institute	Nihon University Hospital Gastroenterology
Institute
Department

Funding Source
Organization	No
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	Nihon University Hospital Clinical Research Review Committee
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
Tel	03-3293-1711
Email	iwao.aya@nihon-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

Other administrative information
Date of disclosure of the study information	2022 Year 04 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	Preinitiation
Date of protocol fixation	2022 Year 02 Month 14 Day
Date of IRB	2022 Year 03 Month 10 Day
Anticipated trial start date	2022 Year 04 Month 04 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 02 Day
Last modified on	2022 Year 04 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053891