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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030254
Receipt No. R000034553
Scientific Title Error estimation of straight-tool surgical navigation using stereoscopic imaging
Date of disclosure of the study information 2017/12/04
Last modified on 2017/12/04

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Basic information
Public title Error estimation of straight-tool surgical navigation using stereoscopic imaging
Acronym Error estimation of straight-tool surgical navigation using stereoscopic imaging
Scientific Title Error estimation of straight-tool surgical navigation using stereoscopic imaging
Scientific Title:Acronym Error estimation of straight-tool surgical navigation using stereoscopic imaging
Region
Japan

Condition
Condition Healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate error in percutaneous straight-tool insertion using stereoscopic image navigation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positional and orientational error between a straight-tool and the optimal alignment.
Key secondary outcomes Sensitivity for the error (including positional and orientational) regarding two lines displayed on PC monitors.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Subjects align a surgical straight tool on a patient model in two types of surgical navigations. Following each of 3 conditions, subjects conduct the task 15 times (total 45 times per one navigation). And then subjects conduct the task 15 times without any guidance by surgical navigation.
Interventions/Control_2 Subjects align a surgical straight tool on a patient model without any guidance by surgical navigation. And then subjects conduct the task in two types of surgical navigations (15 times in each navigation and totally 45 times per one navigation).
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy subject.
2. A doctor or a student who belongs to a school of medicine.
Key exclusion criteria 1. A minor.
2. Individuals who don't have enough judgement.
3. Individuals who don't have enough eyesight (Putting on glasses or contact lens are acceptable).
4. Individuals who have anamnesis of diseases that can affect or be affected by this experiment.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YOSHIKAZU NAKAJIMA
Organization Tokyo Medical and Dental University
Division name Institute of Biomaterials and Bioengineering
Zip code
Address 2-3-10 Kanda-Surugadai Chiyoda-ku, Tokyo 101-0062, Japan
TEL 03-5280-8060
Email nakajima.bmi@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name YOSHIKAZU NAKAJIMA
Organization Tokyo Medical and Dental University
Division name Institute of Biomaterials and Bioengineering
Zip code
Address 2-3-10 Kanda-Surugadai Chiyoda-ku, Tokyo 101-0062, Japan
TEL 03-5280-8060
Homepage URL
Email nakajima.bmi@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development(AMED)
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 東京医科歯科大学 生体材料工学研究所(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 04 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 11 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 04 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 12 Month 04 Day
Last modified on
2017 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034553

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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