UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023263 |
|---|---|
| Receipt number | R000026808 |
| Scientific Title | Verifying the accuracy of neuronavigation system affected by the surgical positioning |
| Date of disclosure of the study information | 2016/07/22 |
| Last modified on | 2017/02/10 18:43:45 |
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Basic information
Public title
Verifying the accuracy of neuronavigation system affected by the surgical positioning
Acronym
Accuracy of neuronavigation system
Scientific Title
Verifying the accuracy of neuronavigation system affected by the surgical positioning
Scientific Title:Acronym
Accuracy of neuronavigation system
Region
| Japan |
Condition
Condition
neurosurgical diseases
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the accuracy of the neuronavigation system in each registration methods or each surgical position
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the accuracy of the neuronavigation system registered by intraoperative CT-based auto-registration method compared with conventional surface marge method.
Key secondary outcomes
1. Deviation from the reference points of neuronavigation system registered by surface marge method in each surgical position.
2. Deviation from the reference points of neuronavigation system registered by intraoperative CT-based auto-registration method in each surgical position.
3. Unavailable events of neuronavigation system registered by intraoperative CT-based auto-registration method.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled neurosurgical procedures with neuronavigation system
Key exclusion criteria
1, Patients who can not examine preoperative CT or MRI
2, Patients who can not undertake general anesthesia.
3, Patients who planed neurosurgical procedure without neuronavigation system
4, Pregnant patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Kuroiwa |
Organization
Osaka Medical College
Division name
Department of Neurosurgery and Endovascular Neurosurgery
Zip code
Address
2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
TEL
+81-72-683-1221
neu040@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motomasa Furuse |
Organization
Osaka Medical College
Division name
Department of Neurosurgery and Endovascular Neurosurgery
Zip code
Address
2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
TEL
+81-72-683-1221
Homepage URL
neu054@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 07 | Month | 21 | Day |
Last modified on
| 2017 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026808
