UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008301 |
|---|---|
| Receipt number | 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 09:39:30 |
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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 ≥ 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
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
Sponsor or person
Institute
First Department of Surgery, Tokyo Medical University
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009213
