臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 06, 2023
Last modified on	Feb. 04, 2025
Trial ID	jRCT1032230493

Scientific Title	Study of usability of Gastrointestinal Endoscopy with a Single-Use Endoscope
Public Title	Study of usability of Gastrointestinal Endoscopy with a Single-Use Endoscope

Contact for Scientific Queries	Name	Matsumura Tomoaki
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
	Telephone	+81-43-222-7171
	E-mail	matsumura@chiba-u.jp
Contact for Public Queries	Name	Fujie Mai
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
	Telephone	+81-43-222-7171
	E-mail	fujiemai@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 06, 2023
Actual date of first enrollment
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing upper gastrointestinal endoscopy at this hospital are eligible for the following 1) Adults who are at least 18 years old and less than 90 years old at the time of consent 2) Patients scheduled to undergo upper gastrointestinal endoscopy 3) Patients who have been fully informed of the study, fully understand it, and have given their free and voluntary written consent to participate in the study.
	Exclusion Criteria	Persons who meet any of the following conditions at the time of obtaining consent are not eligible 1) Those who do not intend to evaluate the stomach during the endoscopy 2) Those who are unable or unwilling to consent to sedation during the endoscopy 3) Patients for whom two or more upper gastrointestinal endoscopic examinations are considered inappropriate. 4) Pregnant, possibly pregnant, or within 28 days postpartum 5) Other patients who are deemed inappropriate for the safe conduct of this study by the Principal Investigator or the Principal Investigator.
	Age Minimum	18age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Persons undergoing upper gastrointestinal endoscopy for suspected gastric cancer or other diseases
Intervention(s)		Observation of the stomach with a single-use endoscope before performing a previously scheduled reuse-endoscopy
Health Condition(s) Keyword		gastric cancer
Intervention(s) Keyword
Health Condition(s) Code		D013274
Intervention(s) Code
Primary Outcome(s)		Agreement rate for diagnosis of gastric cancer (presence or absence and location of gastric cancer)
Secondary Outcome(s)		Secondary efficacy endpoints The concordance rate between the boundary of atrophic gastritis and the diagnosis based on the Kimura-Takemoto classification. Agreement rate of endoscopic diagnosis of gastritis The concordance rate of the presence or absence of lesions other than carcinoma. Secondary safety endpoints Complications (incidentalities)

Primary Sponsor

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Clinical Research Initiation-Fund (of Chiba University Hospital)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	Nov. 20, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Feb. 04, 2025	(this page)	Changes
4	June. 04, 2024	Detail	Changes
3	April. 05, 2024	Detail	Changes
2	April. 05, 2024	Detail	Changes
1	Dec. 06, 2023	Detail

List of change history