UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018493 |
|---|---|
| Receipt number | R000021409 |
| Scientific Title | An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection |
| Date of disclosure of the study information | 2015/07/30 |
| Last modified on | 2019/10/08 10:54:14 |
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Basic information
Public title
An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection
Acronym
An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection
Scientific Title
An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection
Scientific Title:Acronym
An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with pulmonary arteries and veins in patients undergoing pulmonary resection
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine and evaluate the safety and performance of applying the LigaSure vessel sealing system to pulmonary arteries and veins in patients undergoing pulmonary resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rates of intra and post-operative bleeding within 28days
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1)Patients scheduled to undergo lung resection or segmentectomy with LigaSure
2)Above 20 years old
3)Performance Status 0-1 (ECOG classification)
4)Patients with preserved major organ function.
5)Consent from the patient for participating in the study is obtaine
Key exclusion criteria
1)Patients with active bacterial and/or fungal infections
2)Patients receiving continued systemic steroids
3)Patients with uncontrolled diabetes mellitus
4)Patients with psychiatric disorder or psychiatric symptoms that would preclude the participation in the study
5)Patients received thoracic radiation or chemotherapy within one year
6)Other patients who are considered by the investigator or sub-investigator as not suitable for participation in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morihito Okada / Kenji Suzuki |
Organization
Hiroshima University Hospital / Juntendo University School of Medicine
Division name
Oncological surgery / General Thoracic Surgery
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037 / 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
TEL
082-257-5555
ymiyata@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Miyata / Kazuya Takamochi |
Organization
Hiroshima University Hospital / Juntendo University School of Medicine
Division name
Oncological surgery / General Thoracic Surgery
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037 / 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-843
TEL
082-257-5555
Homepage URL
ymiyata@hiroshima-u.ac.jp
Sponsor or person
Institute
Oncological surgery, Hiroshima University Hospital / Department of Thoracic Surgery, Juntendo University Main Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
| 2015 | Year | 07 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective, single-arm, multicenter, observational study
Management information
Registered date
| 2015 | Year | 07 | Month | 30 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021409
