UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009717
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

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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 Resection

Acronym

An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with Pulmonary Resection

Scientific Title

An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with Pulmonary Resection

Scientific Title:Acronym

An Observational Study of the Safety and Performance of the Vessel Sealing System (LigaSure) in patients with Pulmonary Resection

Region

Japan


Condition

Condition

Benign or malignant pulmonary lesions

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)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.

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


Email



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 113-8431

TEL


Homepage URL


Email



Sponsor or person

Institute

Oncological surgery, Hiroshima University Hospital / Department of Thoracic Surgery, Juntendo University Main Hospital

Institute

Department

Personal name



Funding Source

Organization

Covidien Japan Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

2013 Year 01 Month 07 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

Terminated

Date of protocol fixation

2012 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 08 Day

Last follow-up date

2014 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

2013 Year 01 Month 07 Day

Last modified on

2014 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011390


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name