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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026543
Receipt No. R000030483
Scientific Title AR navigation system of laparoscopic surgery based on preoperative CT or MRI
Date of disclosure of the study information 2017/03/14
Last modified on 2018/09/18

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Basic information
Public title AR navigation system of laparoscopic surgery based on preoperative CT or MRI
Acronym AR navigation system of laparoscopic surgery based on preoperative CT or MRI
Scientific Title AR navigation system of laparoscopic surgery based on preoperative CT or MRI
Scientific Title:Acronym AR navigation system of laparoscopic surgery based on preoperative CT or MRI
Region
Japan

Condition
Condition Liver tumor, breast cancer, colon cancer, cholelithiasis, inguinal hernia, renal tumor, adrenal gland tumor, retroperitoneal tumor, urologic disease, lung disease, and mediastinal tumor
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Breast surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Development of AR navigation system of laparoscopic surgery based on preoperative CT or MRI
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)patients with Liver tumor, breast cancer, colon cancer, cholelithiasis, inguinal hernia, renal tumor, adrenal gland tumor, retroperitoneal tumor, urologic disease, lung disease, and mediastinal tumor
(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 50

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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 14 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 03 Month 14 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030483

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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