UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017371 |
|---|---|
| Receipt number | R000020144 |
| Scientific Title | Video-assisted thoracoscopic surgery using mobile computed tomography: New method for locating of small lung nodules |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2015/05/01 13:23:45 |
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Basic information
Public title
Video-assisted thoracoscopic surgery using mobile computed tomography: New method for locating of small lung nodules
Acronym
Video-assisted thoracoscopic surgery using mobile computed tomography
Scientific Title
Video-assisted thoracoscopic surgery using mobile computed tomography: New method for locating of small lung nodules
Scientific Title:Acronym
Video-assisted thoracoscopic surgery using mobile computed tomography
Region
| Japan |
Condition
Condition
small lung nodules
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the usefulness of surgery that performed based on intraoperative CT images using the O-arm for small lung tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The results of VATS lung resection using the O-arm
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
The mobile computed tomography
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
In our institute, clinical indication for preoperative localization were on the basis of the following preoperative CT findings: (1) maximum diameter of nodule of 10 mm or less, (2) minimum distance between the visceral pleura and superior border of the nodule of 10 mm or more, (3) GGN which had no contact with visceral pleura .
Key exclusion criteria
No criteria
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuto Ohtaka |
Organization
Steel Memorial Muroran Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
1-45 Chiribetsu-cho, Muroran, Hokkaido 050-0076, Japan
TEL
81143444650
kit_katton0803@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuto Ohtaka |
Organization
Steel Memorial Muroran Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
1-45 Chiribetsu-cho, Muroran, Hokkaido 050-0076, Japan
TEL
81143444650
Homepage URL
kit_katton0803@yahoo.co.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Steel Memorial Muroran Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | 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
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020144
