UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034164 |
|---|---|
| Receipt number | R000038950 |
| Scientific Title | Evaluation of lung segmentectomy for intraoperative selective intra-bronchial air supply catheter |
| Date of disclosure of the study information | 2018/09/30 |
| Last modified on | 2021/09/25 21:32:54 |
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Basic information
Public title
Evaluation of lung segmentectomy for intraoperative selective intra-bronchial air supply catheter
Acronym
Lung segmentectomy by intora-bronchial air supply catheter
Scientific Title
Evaluation of lung segmentectomy for intraoperative selective intra-bronchial air supply catheter
Scientific Title:Acronym
Lung segmentectomy by intora-bronchial air supply catheter
Region
| Japan |
Condition
Condition
Lung tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) Evaluation of intraoperative use of intratracheal air supply catheter
2) Homogenization of procedures in lung segmentectomy and confirmation of reproducibility
Basic objectives2
Others
Basic objectives -Others
Research on surgery and procedures
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of lung segmentectomy
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
Use of air supply catheter in lung segmentectomy
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
1.Primary lung cancer, metastatic lung tumor, benign tumor patients who can undergo lung segmentectomy under general anesthesia.
2.Patients with normal lung function
3.Patients with interstitial pneumonia
4.Patients with Pulmonary emphysema >2 degrees in Gold classification
5.Patients of age 20 years or older
6.Patients who gave sufficient consultation on participation of this study and obtained consent
Key exclusion criteria
1.History of Allergy to Material
2.Bronchial traveling abnormality
3.Dementia and disturbance of consciousness
4.Cases judged inappropriate by a doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kobayashi Masashi |
Organization
Tokyo medical and Dental University
Division name
Department of Thoracic Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bukyo-ku, Tokyo
TEL
03-5803-4072
mkobthsr@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo medical and Dental University
Division name
Department of Thoracic Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bukyo-ku, Tokyo
TEL
03-5803-4072
Homepage URL
mkobthsr@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and Dental University
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
Tokyo medical and Dental University
Address
1-5-45 Yushima, Bukyo-ku, Tokyo
Tel
03-5803-5096
mkan-rinsho.adm@tmd.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
| 2018 | Year | 09 | Month | 30 | 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
| 2018 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038950
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
