UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033338 |
|---|---|
| Receipt number | R000038007 |
| Scientific Title | Usability Evaluation of Surgical Robots |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/07/31 10:30:51 |
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Basic information
Public title
Usability Evaluation of Surgical Robots
Acronym
Usability Evaluation of Surgical Robots
Scientific Title
Usability Evaluation of Surgical Robots
Scientific Title:Acronym
Usability Evaluation of Surgical Robots
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Various surgical support robots have been developed, ranging from remote-controlled robots (master slave type) to hand-held robots (handhelds). Though various operation interfaces for the operation robot have been produced experimentally, it has not been clarified which operation interface is the most excellent.
The purpose of this study is to compare the maneuvering methods of multiple surgical support robots using simulated organs. As a preliminary step to the evaluation by the doctor, the basic characteristics such as the time required for the work are measured by the subject who has no clinical experience.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time required for the work
Key secondary outcomes
trajectory of the robot (arm travel distance), force applied to the simulated organ, myoelectric potential of the subject, image of the endoscope, image of the whole experimental facility
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Prototype of a master-slave type surgical robot (With force feedback function)
Interventions/Control_2
Prototype of a master-slave type surgical robot (Without force feedback function)
Interventions/Control_3
Prototype of a handheld surgical robot
Interventions/Control_4
Commercially available laparoscopic forceps and needle holders
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy people
Key exclusion criteria
People with difficulty in using a stereoscopic 3D display
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kanno |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
1010062
Address
2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-5280-8163
kanno.bmc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kanno |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
1010062
Address
2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-5280-8163
Homepage URL
kanno.bmc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
Tel
03-5280-8004
zaikensoumu.adm@tmd.ac.jp
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
| 2019 | Year | 04 | Month | 01 | 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
| 2018 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 09 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038007
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
