UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022175 |
|---|---|
| Receipt number | R000025544 |
| Scientific Title | Study for efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection using da Vinci surgical system |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2019/05/08 09:44:55 |
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Basic information
Public title
Study for efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection using da Vinci surgical system
Acronym
Efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection
Scientific Title
Study for efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection using da Vinci surgical system
Scientific Title:Acronym
Efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection
Region
| Japan |
Condition
Condition
Mediastinal tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Operative time, blood loss, perioperative complications, histopathological findings, and postoperative outcome will be evaluated for assessment of efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operative time, blood loss, perioperative complications, histopathological findings, and postoperative outcome
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Mediastinal tumor resection will be performed by robot-assisted thoracoscopic surgery using da Vinci surgical system.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
5cm or smaller sized mediastinal tumor diagnosed by CT scan
No obvious invasion to adjacent organ
Informed consent obtained from the patient
Key exclusion criteria
Severe cardiac disorders
Severe pulmonary disorders
Impossible cessation of anticoagulants
Severe obesity (BMI>35)
Patients without informed consent
Any other reasons considered as inappropriate for this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Suzuki |
Organization
Ibaraki Prefectural Central Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
6528, Koibuchi, Kasama, Ibaraki 309-1793, Japan
TEL
0296-77-1121
hsuzuki-jpn@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Suzuki |
Organization
Ibaraki Prefectural Central Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
6528, Koibuchi, Kasama, Ibaraki 309-1793, Japan
TEL
0296-77-1121
Homepage URL
hsuzuki-jpn@umin.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural Central Hospital
Organization
Division
Category of Funding Organization
Self funding
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 | 05 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025544
