UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031304 |
|---|---|
| Receipt number | R000035734 |
| Scientific Title | Robotic atrial septal defect closure using da Vinci surgical system: A safety and feasibility study |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2019/01/17 21:16:47 |
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Basic information
Public title
Robotic atrial septal defect closure using da Vinci surgical system: A safety and feasibility study
Acronym
Robotic atrial septal defect closure using da Vinci surgical system: A safety and feasibility study
Scientific Title
Robotic atrial septal defect closure using da Vinci surgical system: A safety and feasibility study
Scientific Title:Acronym
Robotic atrial septal defect closure using da Vinci surgical system: A safety and feasibility study
Region
| Japan |
Condition
Condition
Atrial septal defect
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We do atrial septal defect closure with da Vinci surgical system at atrial septal defect 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
leakage of atrial septal defect closure
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, after the start of cardiopulmonary bypass, the robot is connected to patient. The atrial septal defect closure with the assist of robot. The robot is rolled out after the atrial septal defect closure.
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) a patient who had indicion of atrial septal defect closure
2) obtained infromed consent
Key exclusion criteria
1) a patient who had past history of open chest surgery
2) a patient who had high deformity of chest (funnel chest, scoliosis)
3) a patient who can not do separate lung ventilation because of poor pulmonary function
4) 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
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
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
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=R000035734
