UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025523 |
|---|---|
| Receipt number | 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 16:01:50 |
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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
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
mfuji@med.nagoya-u.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029378
