UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026543
Receipt number 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 2023/03/27 15:39:54

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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 Makoto
Middle name
Last name HASHIDUME

Organization

Kyushu University Hospital

Division name

Department of Advance Medicine and Innovative Technology

Zip code

811-8582

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 Yoshihiro
Middle name
Last name NAGAO

Organization

Kyushu University Hospital

Division name

Department of Advance Medicine and Innovative Technology

Zip code

811-8582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5466

Homepage URL

https://www.camit.org/index.html

Email

nagao.yoshihiro.796@m.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

Kyushu University Hospital IRB

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

Tel

092-642-5082

Email

byskenkyu@jimu.kyushu-u.ac.jp


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

2017 Year 03 Month 14 Day

Anticipated trial start date

2017 Year 03 Month 14 Day

Last follow-up date

2024 Year 09 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

2023 Year 03 Month 27 Day



Link to view the page

Value
https://center6.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