UMIN-CTR Clinical Trial

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
Email	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/
Email	ryotas@med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030479