UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026544 |
|---|---|
| Receipt number | R000030479 |
| Scientific Title | AR navigation system of laparoscopic surgery based on preoperative CT or MRI for children |
| Date of disclosure of the study information | 2017/03/14 |
| Last modified on | 2022/05/24 15:46:54 |
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Basic information
Public title
AR navigation system of laparoscopic surgery based on preoperative CT or MRI for children
Acronym
AR navigation system of laparoscopic surgery based on preoperative CT or MRI for children
Scientific Title
AR navigation system of laparoscopic surgery based on preoperative CT or MRI for children
Scientific Title:Acronym
AR navigation system of laparoscopic surgery based on preoperative CT or MRI for children
Region
| Japan |
Condition
Condition
surgery for the benign tumor, the malignant tumor, imperforate anus, hydronephrosis, congenital biliary dilatation and biliary atresia
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of AR navigation system of laparoscopic surgery based on preoperative CT or MRI for children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of AR navigation system
Key secondary outcomes
Accuracy of AR navigation system
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The markers attached the body surface were measured by Polaris during the surgery. And it was compared from markers during preoperative CT images. Based on these informations, AR navigation was performed for laparoscopic surgery.
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
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)the patient are under 16 years old and they are treated by the surgery for the benign tumor, the malignant tumor, imperforate anus, hydronephrosis, congenital biliary dilatation and biliary atresia
(2)hospitalized patient
(3)the confirmation of the indication of the AR navigation system
(4)Patients with paper-based agreement to participate in this study
Key exclusion criteria
(1) patient with pacemaker
(2)the patients have no indication of AR navigation system
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto HASHIDUME |
Organization
Kyushu University Hospital
Division name
Department of Advance Medicine and Innovative Technology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5992
mhashi@dem.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota SOUZAKI |
Organization
Kyushu University Hospital
Division name
Pediatric Surgery
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5573
Homepage URL
http://www.med.kyushu-u.ac.jp/pedsurg/
ryotas@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2022 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030479
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
