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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030085
Receipt No. R000034346
Scientific Title Assessment of Usefulness of Surgical Navigation and Telemedicine using Augmented Reality Device
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/22

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Basic information
Public title Assessment of Usefulness of Surgical Navigation and Telemedicine using Augmented Reality Device
Acronym Assessment of Usefulness of Surgical Navigation and Telemedicine using Augmented Reality Device
Scientific Title Assessment of Usefulness of Surgical Navigation and Telemedicine using Augmented Reality Device
Scientific Title:Acronym Assessment of Usefulness of Surgical Navigation and Telemedicine using Augmented Reality Device
Region
Japan

Condition
Condition The patients who need improvement of the body surface contour
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We study the usefulness of simple surgical navigation / telemedicine using commonly available augmented reality device.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In surgical navigation, the coincidence rate between "the position of the 3D model projected by the navigation" and "the actual surgical field"

Key secondary outcomes In telemedicine, the questionnaire evaluates whether the intention of the mentor has been communicated to the surgeon.
Operability of augmented reality device

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 Using augmented reality device during the operation, we project the 3D image of the affected part on the surgical field.
Using augmented reality device during the operation, the surgeon receives the guidance by mentors from a distance place.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who need improvement of the body surface contour at Osaka Medical College Hospital / Chikamori Hospital / Hirakata City Hospital.
Key exclusion criteria Patients judged as being inappropriate for the subjects of the study by researchers.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Mitsuno
Organization Osaka Medical College
Division name Plastic and Reconstructive Surgery
Zip code
Address Daigakumachi, 2-7, Takatsuki, Osaka, Japan
TEL 072-683-1221
Email pla083@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Mitsuno
Organization Osaka Medical College
Division name Plastic and Reconstructive Surgery
Zip code
Address Daigakumachi, 2-7, Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email pla083@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 大阪医科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 12 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
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2017 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034346

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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