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, GIST
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Development of a real-time haptic sensing system to detect an intraluminal tumor during laparoscopic surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Possibility of detecting an early gastric cancer lesion, gastric GIST, or marking clips with novel sensing system.
Key secondary outcomes	Feasibility of this system.

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	Device,equipment
Interventions/Control_1	Exploration of an intraluminal lesion or marking clip with novel sensing forceps.
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. gastric cancer: cStage IA(T1N0), cStage IB(T1N1, T2N0), or Stage IIA(T3N0), or gastric GIST (intraluminal growing type) 2. PS ECOG 0 or 1 3. no history of previous open surgery in upper abdomen.
Key exclusion criteria	1. febrile more than 38 degrees. 2. pregnancy 3. unstable angina or histry of cardiac infarction within 6 months. 4. poor-controlled hypertension 5. poor-controlled DM
Target sample size	20

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

Public contact
Name of contact person	Michitaka Fujiwara
Organization	Nagoya University
Division name	Clinical Simulation Center, Graduate School of Medicine
Address	65, Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2238
Homepage URL
Email	mfuji@med.nagoya-u.ac.jp

Sponsor
Institute	Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya Institute of Technology
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	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 27 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 10 Month 30 Day

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

Management information
Registered date	2017 Year 01 Month 04 Day
Last modified on	2017 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029378