UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tactile sensing system for laparoscopic surgery
Title of the study (Brief title)	Tactile sensing system for laparoscopic surgery
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Ehe effectiveness of tactile sensing system for laparoscopic surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The detection rate of early gastric cancer lesion or marked clip
Key secondary outcomes

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	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	operation
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	80 years-old >=
Gender	Male and Female
Key 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.
Key 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.
Target sample size	20

Research contact person
Name of lead principal investigator	Michitaka FUJIWARA
Organization	Nagoya University Graduate School of Medicine
Division name	Clinical Simulation Center
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2238
Email	mfuji@med.nagoya-u.ac.jp

Public contact
Name of contact person	Chie TANAKA
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2245
Homepage URL
Email	chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 07 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 04 Day
Last modified on	2018 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029097