UMIN-CTR Clinical Trial

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
Email	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
Email	kanno.bmc@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038007