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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 August 2015 |
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Main ID: |
NCT01349426 |
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Date of registration:
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04/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ligasure II: Standard Stapling Versus Ligasure
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Scientific title:
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Standard Stapling Technique Versus Bipolar Fusion (With The Ligasure Impact and Force Triad Generator) To Complete The Fissure During Major Lung Resection: A Prospective Randomized Controlled Trial |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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172 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01349426 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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TIFFET Olivier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Sainte-Etienne |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients older than 18 years
- Patients scheduled for thoracotomy, lobectomy or bilobectomy
- Patients must give informed consent
Exclusion Criteria:
- Patient is unwilling or unable to provide informed consent
- Patients who can not tolerate thoracotomy
- Patients who require extensive dissection to release adhesions which may result in
air leak and/or bleeding unrelated to the quality of the parenchymal seal achieved by
the devices in question
- Patients with no parenchymal bridge between lobes; 100% complete fissure.
- Patients with complete incomplete fissure with a thickness > 1.5 cm measure
intraoperatively
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Resection
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Intervention(s)
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Device: LigaSure Force Triad Vessel Sealing System
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Primary Outcome(s)
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Rates of post-operative air leak between the two techniques
[Time Frame: Day 1]
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Secondary Outcome(s)
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Compare the number of lung stitches between LigaSure device and standard staplers
[Time Frame: Day 1]
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Evaluate the cost of LigaSure vs standard staplers in similar procedures including the cost of each instrument and the staple loads fired.
[Time Frame: Day 1]
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Secondary ID(s)
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2010-A00666-33
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1008067
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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