Unique ID issued by UMIN | UMIN000009717 |
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Receipt number | R000011390 |
Scientific Title | An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with Pulmonary Resection |
Date of disclosure of the study information | 2013/01/07 |
Last modified on | 2014/01/07 09:10:51 |
An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with Pulmonary Resection
An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with Pulmonary Resection
An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with Pulmonary Resection
An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with Pulmonary Resection
Japan |
Benign or malignant pulmonary lesions
Chest surgery |
Malignancy
NO
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.
Safety,Efficacy
Incidence rates of intra and post-operative bleeding within 28days
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients scheduled to undergo lung resection or segmentectomy with LigaSure.
2)20 years old or older.
3)Patients with ECOG Performance Status of 0 to 1.
4)Patients with preserved major organ function.
5)Written informed consent is obtained from the patient.
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.
200
1st name | |
Middle name | |
Last name | Morihito Okada / Kenji Suzuki |
Hiroshima University Hospital / Juntendo University School of Medicine
Oncological surgery / General Thoracic Surgery
1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037 / 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
1st name | |
Middle name | |
Last name | Yoshihiro Miyata / Kazuya Takamochi |
Hiroshima University Hospital / Juntendo University School of Medicine
Oncological surgery / General Thoracic Surgery
1-2-3 Kasumi, Minami-ku, Hiroshima-city, Hiroshima 734-0037 / 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
Oncological surgery, Hiroshima University Hospital / Department of Thoracic Surgery, Juntendo University Main Hospital
Covidien Japan Inc.
Profit organization
NO
2013 | Year | 01 | Month | 07 | Day |
Unpublished
Terminated
2012 | Year | 11 | Month | 15 | Day |
2014 | Year | 01 | Month | 08 | Day |
2014 | Year | 03 | Month | 31 | Day |
A prospective, single-arm, multicenter, observational study
2013 | Year | 01 | Month | 07 | Day |
2014 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011390
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