臨床研究等提出・公開システム

Date of registration	May. 21, 2024
Last modified on	May. 21, 2024
Trial ID	jRCT1050240040

Scientific Title	An exploratory study of lung tumor location identification using extended reality-aided marking (Extended reality-aided tumor marking )
Public Title	A study to establish the feasibility and safety of using XR technology to identify tumor location in the lung for sublobar resection. (XR technology in the lung for sublobar resection)

Contact for Scientific Queries	Name	Tanaka Yugo
	Affiliation	Kobe University Hospital
	Address	7-5-2, Kusunoki-cho, Chuo-ward, Kobe, Japan
	Telephone	+81-78-382-5111
	E-mail	tanakay@med.kobe-u.ac.jp
Contact for Public Queries	Name	Shinya Tane
	Affiliation	Kobe University Graduate School of Medicine
	Address	7-5-2, Kusunoki-cho, Chuo-ward, Kobe, Japan
	Telephone	+81-78-382-5750
	E-mail	tanakay@med.kobe-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 21, 2024
Actual date of first enrollment		Nov. 10, 2023
Target sample size		20
Study Type		Observational
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	1. Lung malignant tumor patients who will receive thoracoscopic sublobar resection. 2. The patints with 18 years old or more, and 79 years old or less 3. The patients having provided signed informed consent. 4. The patients who have had blood examination (white blood cells, hemoglobin, platelets, total bilirubin, AST, ALT, serum creatinine, CRP) ,chest X-ray and CT scan of chest with 56 days
	Exclusion Criteria	1. The pregnant patients. 2. The patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult. 3. The patients who are judged to be eligible by investigators.
	Age Minimum	18age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		lung malignant tumor
Intervention(s) Keyword		Extended reality, Sublobar resection, Marking
Primary Outcome(s)		The difference between the actual distance from the tumor to the margin and the distance from the identified marking point on the extended reality image to the margin.
Secondary Outcome(s)		Duration of surgery Adverse events

Primary Sponsor	Kobe University Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Kobe University Clinical Research Ethical Committee
Address	7-5-2, Kusunoki-cho, Chuo-ward, Kobe, Japan, Hyogo
Telephone	+81-78-382-6669
E-Mail	cerb@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 31, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None