UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007776
Receipt number R000009157
Scientific Title Clinical study of robot-assisted otolaryngological and head & neck surgery using da Vinci Surgical System
Date of disclosure of the study information 2012/06/16
Last modified on 2015/04/22 18:17:23

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Basic information

Public title

Clinical study of robot-assisted otolaryngological and head & neck surgery using da Vinci Surgical System

Acronym

Clinical study of robot-assisted otolaryngological and head & neck surgery

Scientific Title

Clinical study of robot-assisted otolaryngological and head & neck surgery using da Vinci Surgical System

Scientific Title:Acronym

Clinical study of robot-assisted otolaryngological and head & neck surgery

Region

Japan


Condition

Condition

Diseases in the field of otolaryngology-head & neck Surgery

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the usability and safety of surgery using da Vinci S Surgical
System

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

overall survival, and recurrence-free survival

Key secondary outcomes

intra- and post-operative adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Surgery using da Vinci S
Surgical System

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with indication of endoscopic
surgery
2) Patients with will to conform with study
protocol

Key exclusion criteria

1) pregnant or potentially pregnant women,
nursing women
2) patients with psychiatric disease
3) patients with severe or complicated medicalconditions, not allowing participation into this protocol

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Juichi Ito

Organization

Kyoto University Graduate School of Medicine

Division name

Otolaryngology-Head & Neck Surgery

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3346

Email

inq@ent.kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ichiro Tateya

Organization

Kyoto University Graduate School of Medicine

Division name

Otolaryngology-Head & Neck Surgery

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3346

Homepage URL


Email

inq@ent.kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

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


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



Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 16 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

2012 Year 04 Month 16 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 01 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

2012 Year 04 Month 16 Day

Last modified on

2015 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009157


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name