UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027443 |
|---|---|
| Receipt number | R000031445 |
| Scientific Title | Clinical trials on safety of mediastinal tumor resection by Da Vinci surgery system. |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2018/04/16 17:15:25 |
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Basic information
Public title
Clinical trials on safety of mediastinal tumor resection by Da Vinci surgery system.
Acronym
Mediastinal tumor resection by Da Vinci surgery system.
Scientific Title
Clinical trials on safety of mediastinal tumor resection by Da Vinci surgery system.
Scientific Title:Acronym
Mediastinal tumor resection by Da Vinci surgery system.
Region
| Japan |
Condition
Condition
Resectable mediastinal tumor.
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the safety of robot assisted mediastinal tumor resection using Da Vinci surgery system in clinical trials.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative adverse events.
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
Robot assisted mediastinal tumor resection with da Vinci surgery 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Complete resectable mediastinal tumor (thymoma, neurogenic tumor, congenital cyst, etc.).
2) It is 20 years old to 80 years old.
3) PS (ECOG) is 0 or 1.
4) There is no history of thoracotomy or high degree of adhesion is not expected in the thoracic cavity.
5) It satisfies all the conditions below. (The latest inspection value within 28 days from the registration date is used for all inspection items.)
- White blood cell count is 3,000 / mm3 or more.
- Platelet count is 100,000 / mm3 or more.
- AST is 100 IU / L or less / ALT is 100 IU / L or less.
- Total bilirubin is 2.0 g / dl or less.
- Serum creatinine is 1.5 mg / dl or more.
6) For patient participation, written consent has been obtained from the patient himself.
Key exclusion criteria
1) Possible pregnancy or lactating women.
2) Psychosis or psychiatric symptoms are merged, and it is judged that participation in the examination is difficult.
3) Continuous systemic administration (ingestion or intravenous) of steroid drugs.
4) I have a history of myocardial infarction within 6 months or unstable angina.
5) Hypertension with poor control is complicated.
6) Diabetes mellitus with poor control.
7) Combined respiratory diseases requiring sustained oxygen therapy.
8) Other cases that the doctor in charge judged inappropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Funai |
Organization
Hamamatsu University School of Medicine.
Division name
First department of surgery.
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan.
TEL
053-435-2276
kfunai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akikazu Kawase |
Organization
Hamamatsu University School of Medicine.
Division name
First department of surgery.
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan.
TEL
053-435-2276
Homepage URL
akawase@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine.
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
| 2017 | Year | 05 | Month | 22 | 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
| 2017 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | 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
| 2017 | Year | 05 | Month | 22 | Day |
Last modified on
| 2018 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031445
