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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024415
Receipt No. R000028097
Scientific Title Clinical study of robotically assisted mammary artery harvesting in patients with coronary artery bypass grafting
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/14

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Basic information
Public title Clinical study of robotically assisted mammary artery harvesting in patients with coronary artery bypass grafting
Acronym Clinical study of robotically assisted mammmary artery harvesting
Scientific Title Clinical study of robotically assisted mammary artery harvesting in patients with coronary artery bypass grafting
Scientific Title:Acronym Clinical study of robotically assisted mammmary artery harvesting
Region
Japan

Condition
Condition Coronary arteriosclerosis including left anterior descending artery stenosis
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate safety and efficacy of robotically assisted mammary artery harvesting in patients with coronary artery bypass grafting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Completeness of robotically assisted mammary artery harvesting in patients with coronary artery bypass grafting
Key secondary outcomes (1) mammary artery harvesting time
(2) mammary artery graft patency
(3) Adverse events of mamary artery harvesting
(4) Adverse events of coronary artery bypass grafting

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
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Endoscopically surgical assist robot
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) patients who are scheduled to undergo coronary artery bypass grafting
(2) age ranged from 20 years to 80 years
(3) Patients who have informed concent
(4) Patients who are clinically stable and have coronary artery stenosis including left anterior decending artery stenosis
Key exclusion criteria (1) Patients who are possibly pregnant or are breast-feeding
(2) patients who have psychosis
(3) Patients who are clinically clitical
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Sawa
Organization Osaka University
Division name Graduate School of Medicine, Department of Cardiovascular Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3160
Email sawa@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Yoshikawa
Organization Osaka University
Division name Graduate School of Medicine, Department of Surgical Therapeutics for Heart Failure
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3154
Homepage URL
Email yoshikawa@surg1.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Osaka University
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
2016 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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
2016 Year 10 Month 14 Day
Last modified on
2016 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028097

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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