UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031300
Receipt number R000035732
Scientific Title Study of safety and efficacy of intrathoracic artery harvest with da Vinci surgical system
Date of disclosure of the study information 2018/02/20
Last modified on 2019/01/17 21:15:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study of safety and efficacy of intrathoracic artery harvest with da Vinci surgical system

Acronym

Study of safety and efficacy of intrathoracic artery harvest with da Vinci surgical system

Scientific Title

Study of safety and efficacy of intrathoracic artery harvest with da Vinci surgical system

Scientific Title:Acronym

Study of safety and efficacy of intrathoracic artery harvest with da Vinci surgical system

Region

Japan


Condition

Condition

ischemic heart disease

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We harvest the intrathoracic artery with da Vinci surgical system at coronary artery bypass grafting operation to ischemic heart disease patients. We analyze the safety and efficacy of it.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Property and patency of intrathoracic artery

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

In operation, robot is set up to patient. The harvest of intrathoracic artery with da Vinci is perfomed. After the harvest of it, the robot is released from the patient.

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

1) The patient who has indication of coronary artery bypass grafting for ischemic heart disease.
2) obtained infromed consent

Key exclusion criteria

1) Past history of open chest surgery
2) High deformity of chest (funnel chest, scoliosis)
3) Difficult to use the intrathoracic artery
4) a patient who can not do separate lung ventilation because of poor pulmonary function
5) a patient whom the principal investigator considers inappropriate for this clinical study

Target sample size

3


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Youhei Ohkawa

Organization

Hokkaido Ohno Memorial Hospital

Division name

Cardiovascular Surgery

Zip code


Address

1-16-1, 2-jo, Miyanosawa, Nishi-ku, Sapporo-shi, Hokkaido,Japan 063-0052

TEL

011-665-0020

Email

ohkawa@cvc-ohno.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Youhei Ohkawa

Organization

Hokkaido Ohno Memorial Hospital

Division name

Cardiovascular Surgery

Zip code


Address

1-16-1, 2-jo, Miyanosawa, Nishi-ku, Sapporo-shi, Hokkaido,Japan 063-0052

TEL

011-665-0020

Homepage URL


Email

ohkawa@cvc-ohno.or.jp


Sponsor or person

Institute

Hokkaido Ohno Memorial Hospital

Institute

Department

Personal name



Funding Source

Organization

Hokkaido Ohno Memorial Hospital

Organization

Division

Category of Funding Organization

Other

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

2018 Year 02 Month 20 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

2018 Year 02 Month 13 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 20 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

2018 Year 02 Month 14 Day

Last modified on

2019 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035732


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name