UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005148
Receipt number R000006114
Scientific Title Clinical validation of patient specific simulator for laparoscopic surgery
Date of disclosure of the study information 2011/02/28
Last modified on 2022/09/05 09:23:12

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Basic information

Public title

Clinical validation of patient specific simulator for laparoscopic surgery

Acronym

Clinical validation of patient specific simulator for laparoscopic surgery

Scientific Title

Clinical validation of patient specific simulator for laparoscopic surgery

Scientific Title:Acronym

Clinical validation of patient specific simulator for laparoscopic surgery

Region

Japan


Condition

Condition

Renal cell carcinoma, Renal pelvis and ureter cancer, Hydronephrosis, Urological disease

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim is to promote clinical usage of patient specific simulator for laparoscopic surgery, to evaluate its consistency, and to improve surgical outcome and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Equality rate of the anatomy between patient specific simulator and actual surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Preoperative rehearsal using patient specific simulator 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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient who is scheduled for laparoscopic surgery with written confined informed consent

Key exclusion criteria

Nothing particular

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazuhide
Middle name
Last name Makiyama

Organization

Yokohama City University

Division name

Department of Urology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2679

Email

makiya@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Kazuhide
Middle name
Last name Makiyama

Organization

Yokohama City University

Division name

Department of Urology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2679

Homepage URL


Email

makiya@yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Urology, Yokohama City University

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

Yokohama city university

Address

3-9 Fukuura Kanazawa-ku Yokohama

Tel

045-370-7627

Email

rinri@yokohama-cu.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



Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 28 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

2010 Year 10 Month 01 Day

Date of IRB

2010 Year 10 Month 01 Day

Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date

2025 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

2011 Year 02 Month 26 Day

Last modified on

2022 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006114


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name