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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031304
Receipt No. 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

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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
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
Institute Hokkaido Ohno Memorial Hospital
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035734

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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