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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025523
Receipt No. R000029378
Scientific Title Tactile sensing system for laparoscopic surgery
Date of disclosure of the study information 2017/01/20
Last modified on 2017/03/01

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Basic information
Public title Tactile sensing system for laparoscopic surgery
Acronym Tactile sensing system for laparoscopic surgery
Scientific Title Tactile sensing system for laparoscopic surgery
Scientific Title:Acronym 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
1st name
Middle name
Last name Michitaka Fujiwara
Organization Nagoya University
Division name Clinical Simulation Center, Graduate School of Medicine
Zip code
Address 65, Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2238
Email mfuji@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michitaka Fujiwara
Organization Nagoya University
Division name Clinical Simulation Center, Graduate School of Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 01 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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