臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 21, 2023
Last modified on	Jan. 28, 2025
Trial ID	jRCTs032230527

Scientific Title	Evaluation of tolerability and normal baseline data collection for a novel test method for early detection of non-obstructive intestinal membrane ischemia (NOMI).
Public Title	Novel Test Method for Non-Obstructive Mesenteric Ischemia (NOMI)

Contact for Scientific Queries	Name	Ohira Gaku
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-ku, Chiba
	Telephone	+81-43-222-7171
	E-mail	ohira@faculty.chiba-u.jp
Contact for Public Queries	Name	Arai Satoko
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-ku, Chiba
	Telephone	+81-43-222-7171
	E-mail	arai-satoko@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 21, 2023
Actual date of first enrollment		Jan. 11, 2024
Target sample size		24
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 with suspected NOMI: Patients suspected of developing NOMI 1) Patients who have given consent to participate in this study, either by themselves or by a surrogate 2) Patients who are 20 years of age or older 3) Patients who have consulted with the Department of Esophagology and Gastroenterology, Chiba University Hospital 4) Patients with abdominal findings such as abdominal pain, abdominal distention, and any of the following (1) Worsening or new onset of circulatory failure (2) Prolonged elevation of Lactate in blood Non-NOMI patients: Control patients without organ failure 1) Patients who are 20 years old or older. 2) Patients who were admitted to the Department of Esophago-Gastrointestinal Surgery, Chiba University Hospital by walking in for scheduled surgery. 3) Patients who have obtained consent for participation in this study from themselves or their significant others.
	Exclusion Criteria	<Exclusion criteria common to both NOMI and non-NOMI patients> 1) Patients who are unable to perform ultrasound examinations due to inability to carry the equipment to the bedside. 2) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding 3) Patients who are deemed by the physician to be inappropriate for the safe conduct of this study <Exclusion criteria for non-NOMI patients> 1) Patients with abdominal symptoms on admission 2) Patients who cannot walk independently
	Age Minimum	20age 0month old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients admitted to the esophago-gastrointestinal surgical ward or ICU (regardless of disease)
Intervention(s)		Perform examination for NOMI using a novel technique with a diagnostic ultrasound system.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Tolerability of new testing methods
Secondary Outcome(s)		Detection rate in each organ

Primary 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

Source of Monetary Support	Future Medicine Education and Research Organization at Chiba University
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, 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
4	Jan. 28, 2025	(this page)	Changes
3	May. 17, 2024	Detail	Changes
2	May. 15, 2024	Detail	Changes
1	Dec. 21, 2023	Detail

List of change history