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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008301
Receipt No. R000009213
Scientific Title A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a Pulmonary Resection
Date of disclosure of the study information 2012/07/01
Last modified on 2018/08/02

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Basic information
Public title A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a Pulmonary Resection
Acronym A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a Pulmonary Resection
Scientific Title A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a Pulmonary Resection
Scientific Title:Acronym A Prospective Single-Center Observational study of the Safety and Performance of the Vessel Sealing System (LigaSure) in a 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 the LigaSure vessel sealing system for processing pulmonary arteries in patients scheduled to undergo pulmonary resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The success rate and results of sealing of pulmonary arteries (under 5 mm in diameter)
Key secondary outcomes The frequency of additional procedures to the sealed sites during surgery. The occurrence frequency of intraoperative and postoperative adverse events, the duration of drain placement, and the duration of hospitalization.

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 in whom LigaSure may be used during such surgery as pulmonary lobectomy and pulmonary segmentectomy
2)Patients aged 20 years or older
3)Patients scheduled to undergo pulmonary lobectomy and pulmonary segmentectomy
4)Patients with ECOG Performance Status 0 to 1
5)Patients with no history of ipsilateral open lung surgery
6)Patients with preserved major organ function
7)Patients who have provided written informed consent for participation in the study
Key exclusion criteria 1)Patients with a history of chest injury or pulmonary lobectomy
2)Patients with non-curative resectable factors of pulmonary cancer such as pleural dissemination and malignant pleural effusion on opening the chest
3)Patients with active bacterial and/or fungal infections
4)Patients receiving continued systemic (oral or intravenous) steroids
5)Patients with uncontrolled diabetes mellitus (HbA1c > 8.0%)
6)Patients with impaired major organ function (CTCAE ver. 4.0 Grade &#8805; 2)
7)Patients with a psychiatric disorder or psychiatric symptoms that would preclude participation in the study
8)Any other patients judged by the doctor in charge to be ineligible as subjects in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiko Ikeda
Organization Tokyo Medical University
Division name First Department of Surgery
Zip code
Address 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical University
Division name First Department of Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute First Department of Surgery, Tokyo Medical University
Institute
Department

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
2012 Year 07 Month 01 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
2011 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective single-arm single-center observational study

Management information
Registered date
2012 Year 06 Month 29 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009213

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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