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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034164
Receipt No. 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 2019/09/01

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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
Middle name
Last name Kobayashi Masashi
Organization Tokyo medical and Dental University
Division name Department of Thoracic Surgery
Zip code
Address 1-5-45 Yushima, Bukyo-ku, Tokyo
TEL 03-5803-4072
Email mkobthsr@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kobayashi Masashi
Organization Tokyo medical and Dental University
Division name Department of Thoracic Surgery
Zip code
Address 1-5-45 Yushima, Bukyo-ku, Tokyo
TEL 03-5803-4072
Homepage URL
Email mkobthsr@tmd.ac.jp

Sponsor
Institute Tokyo medical and Dental University
Institute
Department

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
Address
Tel
Email

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 10 Month 01 Day
Last follow-up date
2020 Year 08 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
2018 Year 09 Month 15 Day
Last modified on
2019 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038950

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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