臨床研究等提出・公開システム

Date of registration	Mar. 19, 2019
Last modified on	Sept. 15, 2021
Trial ID	jRCTs042180117

Scientific Title	Tactile sensing system for laparoscopic surgery (TSSLS)
Public Title	Tactile sensor for laparoscopic surgery (TSLS)

Completion date	Mar. 31, 2020
Result actual enrolment	10
Baseline Characteristics	- early gastric cancer - gastric GIST (intraluminal growth type)
Participant flow	Scanning was carried out in planned 10 cases.
Adverse events	none.
Outcome measures	One of the 10 cases was excluded from the analysis because the lesion was found from the serosal surface. The lesions were correctly detected in 1 of the remaining 9 cases. In all cases, the operations were pefrmed without any hindrance, and no interference with other surgical devices was observed.
Brief summary	This system is effective for detecting the lesion invisible from the serosal surface, and it is considered that there are no major problems in its practical application.
Date of posting of results summaries	Jan. 29, 2021
Date of the first journal publication of results	Jan. 01, 2021
URL hyperlink(s) related to results and publications	http://doi.org/10.1007/978-981-15-8979-9

Plan to share IPD	No
Plan description	IPD data is published in the above book.
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs042180117

Contact for Scientific Queries	Name	Fujiwara Michitaka
	Affiliation	Nagoya University Hospital
	Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi
	Telephone	+81-52-744-2999
	E-mail	mfuji@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Fujiwara Michitaka
	Affiliation	Nagoya University Hospital
	Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aichi
	Telephone	+81-52-744-2999
	E-mail	mfuji@med.nagoya-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 18, 2017
Actual date of first enrollment		Mar. 22, 2017
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Histologically proven gastric adenocarcinoma. 2) cStage IA(T1N0) or IB(T1N1, T2[MP]N0) or IIA(T3[SS]N0). 3) PS(ECOG) of 0 or 1. 4) No history of upper abdominal surgery.
	Exclusion Criteria	1) Infectious disease with systemic therapy indicated. 2) Body temperature of 38 or more degrees Celsius. 3) Women during pregnancy or breast-feeding. 4) Severe mental disease. 5) Continuous systemic steroid therapy. 6) Unstable angina pectoris, or history of myocardial infarction within six months. 7) Uncontrollable hypertension. 8) Uncontrollable diabetes millutus. 9) Severe respiratory disease requiring continuous oxygen therapy.
	Age Minimum	20age old
	Age Maximum	80age old
	Gender	Both
Health Condition(s) or Problem(s) Studied		gastric cancer, gastric GIST
Intervention(s)		Identify the location of the lesion by this laparoscopic tactile sensing system.
Health Condition(s) Keyword		gastric cancer
Primary Outcome(s)		Determine whether lesion or marker clip position can be detected.
Secondary Outcome(s)		- Investigate whether the display attached to the operator interferes with the operation. - Investigate whether the display attached to the operator interferes with other surgical instruments

Name of Certified Review Board	Nagoya University Ethical Committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 28, 2019

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 15, 2021	(this page)	Changes
1	Mar. 19, 2019	Detail

List of change history