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Ligasure II: Standard Stapling Versus Ligasure

NCT01349426 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2015-07-28

No results posted yet for this study

Summary

Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.

Conditions

  • Lung Resection

Interventions

DEVICE

LigaSure Force Triad Vessel Sealing System

Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • TIFFET Olivier, MD · CHU Sainte-Etienne

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349426 on ClinicalTrials.gov