UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2016 Year 10 Month 20 Day
Date of IRB	2016 Year 11 Month 09 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2021 Year 03 Month 16 Day
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	2020 Year 08 Month 17 Day

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