UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048814 |
|---|---|
| Receipt number | R000055630 |
| Scientific Title | Research of Robot-Assisted Thoracoscopic Surgery lung lobectomy for lung cancer with da Vinci Si Surgical System |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2024/03/18 11:12:03 |
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Basic information
Public title
Research of Robot-Assisted Thoracoscopic Surgery lung lobectomy for lung cancer with da Vinci Si Surgical System
Acronym
Research of Robot-Assisted Thoracoscopic Surgery lung lobectomy for lung cancer with da Vinci Si Surgical System
Scientific Title
Research of Robot-Assisted Thoracoscopic Surgery lung lobectomy for lung cancer with da Vinci Si Surgical System
Scientific Title:Acronym
Research of Robot-Assisted Thoracoscopic Surgery lung lobectomy for lung cancer with da Vinci Si Surgical System
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the research is to investigate the safety during the introduction of Robot-Assisted Thoracoscopic Surgery lung lobectomy with da Vinci Si Surgical System.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
duration of surgery, duration of anesthesia, intraoperative blood loss, postoperative adverse event
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Robot-Assisted Thoracoscopic Surgery lung lobectomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with lung cancer from clinical stage 1a to 2a
Patients who are able to understand informed consent
Key exclusion criteria
Patients who have severe comorbidity
(angina, myocardial infarction, severe arrythmia, uncontrolled diabetes, malignant hypertention, hemorrhagic diathesis, anemia, renal dysfunction, liver dysfunction, bacterial infection, interstitial pneumonia, drug allergy, glaucoma, subarachnoid hemorrhage, unruptured cerebral aneurysm, minors)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Jichi Medical University
Division name
Department of General Thoracic Surgery
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285587368
tcvyamap@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Jichi Medical University
Division name
Department of General Thoracic Surgery
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285587368
Homepage URL
tcvyamap@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical 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
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
Tel
0285587368
tcvyamap@jichi.ac.jp
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
| 2022 | Year | 09 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055630
