UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024415 |
|---|---|
| Receipt number | 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 | 2020/08/17 15:22:06 |
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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
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
yoshikawa@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028097
