UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030254 |
|---|---|
| Receipt number | 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 16:05:44 |
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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
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
nakajima.bmi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034553
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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